Document ID: FDA-2009-N-0114-0001
Agency: fda
Document Type: Proposed Rule
Title: Implementation of Device Registration and Listing Requirements Enacted in the Public Health Security and Bioterrorism Preparedness and  Response Act of 2002, the Medical Device User Fee and Modernization Act  of 2002, and Title II of the Food and Drug Administration Amendments Act of 2007
Posted Date: 2010-03-26T04:00Z

[Federal Register: March 26, 2010 (Volume 75, Number 58)]
[Proposed Rules]               
[Page 14510-14538]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26mr10-15]                         

[[Page 14510]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 807

[Docket No. FDA-2009-N-0114]
RIN 0910-AF88

 
Implementation of Device Registration and Listing Requirements 
Enacted in the Public Health Security and Bioterrorism Preparedness and 
Response Act of 2002, the Medical Device User Fee and Modernization Act 
of 2002, and Title II of the Food and Drug Administration Amendments 
Act of 2007

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration is proposing to amend its 
regulations governing medical device establishment registration and 
device listing. The proposed revisions would modify FDA's current 
regulations at part 807 (21 CFR part 807) to reflect recent statutory 
amendments to the device registration and listing provisions of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food and Drug 
Administration Amendments Act of 2007 (FDAAA), which was enacted on 
September 27, 2007, amended section 510 of the FD&C Act by requiring 
domestic and foreign device establishments to begin submitting their 
registration and device listing information to FDA by electronic means 
rather than on paper forms, and also specified the timeframes when 
establishments are required to submit such information. In accordance 
with FDAAA, the agency launched FDA's Unified Registration and Listing 
System (FURLS), and Internet-based registration and listing system. 
FDAAA requires electronic submission of device registration and listing 
information unless FDA grants a waiver request.
    In addition, this proposal would facilitate FDA's collection of 
additional registration information from foreign establishments as 
required by the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 (Bioterrorism Act). It also would update 
certain provisions in part 807 to improve the quality of registration 
and listing information available to FDA. FDA relies on having complete 
and accurate registration and listing information in order to 
accomplish a number of important public health objectives.

DATES: Submit written or electronic comments on the proposed rule by 
June 24, 2010. Submit comments on information collection issues under 
the Paperwork Reduction Act of 1995 by April 26, 2010, (see the 
``Paperwork Reduction Act of 1995'' section of this document). See 
sections IX and X of this document for the proposed effective and 
proposed compliance dates of a final rule based on this document.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0114 and RIN number 0910-AF88, by any of the following methods, 
except that comments on information collection issues under the 
Paperwork Reduction Act of 1995 must be submitted to the Office of 
Regulatory Affairs, Office of Management and Budget (OMB) at FAX: 202-
395-7285, or e-mail comments to OIRA_submission@omb.eop.gov. Please 
mark your comments to the attention of the FDA desk officer and 
reference this rule.
Electronic Submissions
Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to http://www.regulations.gov, including 
any personal information provided. For additional information on 
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number found in brackets in the heading of this document into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Theresa McDonald, Center for Devices 
and Radiological Health (HFZ-307), Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5823.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Summary of Current Registration and Listing Requirements
    A. Summary of Section 510 of the FD&C Act (21 U.S.C. 360)
    B. Summary of Current Registration and Listing Regulations
III. Highlights of the Proposed Changes to the Current Registration and 
Listing Requirements
IV. Description of the Proposed Rule
    A. General
    B. Registration
    C. Listing
    D. Electronic Format
    E. Miscellaneous
    F. Conforming Actions
V. Legal Authority
VI. Analysis of Economic Impacts
    A. The Need for Regulation
    B. Background
    C. The Proposed Regulation
    D. Estimated Impacts
    E. Impact on Small Entities
VII. Paperwork Reduction Act of 1995
    A. Statutory Compliance
    B. Transition Process From Paper to Electronic Submission
VIII. Environmental Impact
IX. Proposed Effective Date
X. Proposed Compliance Dates
XI. Federalism
XII. Request for Comments
XIII. References

I. Background

    We originally published establishment registration regulations for 
medical devices in the Federal Register of September 3, 1976 (41 FR 
37458) (proposed rule) and August 23, 1977 (42 FR 42520) (final rule), 
and device listing regulations in the Federal Register of September 30, 
1977 (42 FR 52808) (proposed rule), and August 25, 1978 (43 FR 37990) 
(final rule).
    These regulations called for establishment registration and device 
listing information to be submitted to the Center for Devices and 
Radiological Health (CDRH) on several paper forms: FDA 2891, 
Registration of Device Establishment; FDA 2891a, Annual Registration of 
Device Establishment; and FDA 2892, Device Listing. Once these forms 
were completed and submitted to FDA, FDA then forwarded them to a data 
entry contractor who entered the information into FDA's device 
registration and listing database.
    In June 2002, section 321 of the Bioterrorism Act amended section 
510(i) of the FD&C Act to require those foreign

[[Page 14511]]

establishments who are required to register with FDA to do so by 
electronic means, and to include additional information identifying 
certain parties involved in the importation of the foreign 
establishment's devices into the United States as part of their 
registration. Subsequently, in October 2002, section 207 of MDUFMA 
further amended section 510 of the FD&C Act by extending the 
requirement for electronic submission of registration information to 
include domestic firms as well as foreign firms. However, when adding 
these new electronic submission requirements, which appear in section 
510(p) of the FD&C Act, Congress chose to delay their implementation so 
that FDA would have an opportunity to first put systems in place to 
accommodate the electronic receipt of registration information. This 
was accomplished by including a requirement in section 510(p) of the 
FD&C Act for the Secretary of the Department of Health and Human 
Services (the Secretary) to make a finding that the electronic receipt 
of registration information was feasible before implementing electronic 
registration.
    As reflected in FDAAA, the most recent legislation establishing 
changes to FDA's device registration and listing program, FDA has now 
developed a system that makes the electronic receipt of device 
registration and listing information feasible. FDAAA amended section 
510(p) of the FD&C Act by eliminating the need for a feasibility 
finding and requiring both establishment registration and device 
listing information to be submitted using electronic means unless FDA 
grants a waiver request. In accordance with FDAAA, FDA's Unified 
Registration and Listing System (FURLS), which is a new Internet-based 
system, became operational on October 1, 2007. FDA believes this 
electronic system will ultimately make the process of submitting 
registration and listing information more efficient for industry and 
will provide faster access to this information for both FDA and 
industry.
    In addition, the new electronic system will allow FDA to more 
effectively gather information concerning marketed devices. We rely on 
having complete and accurate registration and listing information to 
accomplish a number of important statutory and regulatory objectives. 
For example, we use registration and listing information to:
     Identify establishments producing marketed medical 
devices;
     Identify establishments producing a specific device when 
that device is in short supply or is needed for a national emergency. 
This information helps us facilitate prompt shipment of devices to the 
places where they are needed most. For example, during a bioterrorism 
incident, we could use device listing information to identify 
establishments that could be helpful in preventing or counteracting the 
deadly effects of biological weapons; with this information, we could 
facilitate prompt shipment of the devices as needed;
     Facilitate the recall of devices marketed by owners or 
operators of device establishments;
     Identify and catalogue marketed devices;
     Administer our postmarketing surveillance programs for 
devices;
     Identify devices marketed in violation of the law;
     Identify and control devices imported or offered for 
import into the country from foreign establishments; and
     Schedule and plan inspections of registered establishments 
under section 704 of the FD&C Act (21 U.S.C. 374).
    We also rely on registration and listing information to help us 
comply with several other statutory provisions. For example, we use 
this information to generate accurate estimates of the number of 
businesses that are affected by our rulemaking activities. These 
estimates help us assess the impact of our regulations on regulated 
industry, which we are required to do under the Regulatory Flexibility 
Act of 1980 (Public Law 96-354) (5 U.S.C. 601-612), as amended by the 
Small Business Regulatory Enforcement Fairness Act of 1996 (Title II of 
Public Law 104-121); the Unfunded Mandates Reform Act of 1995 (Public 
Law 104-4) (2 U.S.C. 1501 et seq.); the Paperwork Reduction Act of 1995 
(the PRA) (44 U.S.C. 3501-3520); Executive Order 12866 (September 30, 
1993); and the Congressional Review Act (section 251 of Public Law 104-
121).
    Registration and listing information will continue to be used for 
all of the important public health purposes outlined previously. The 
electronic submission of registration and listing information allows us 
to use such information more quickly and effectively to carry out all 
of the activities described previously.
    In addition, electronic submission of registration and listing 
information furthers the purpose of the Government Paperwork 
Elimination Act of 1998 (Public Law 105-277, Title XVII) (GPEA). GPEA 
requires Federal agencies to give persons who are required to maintain, 
submit, or disclose information, the option of doing so electronically 
when practicable as a substitute for paper, and to use electronic 
authentication (electronic signature) methods to verify the identity of 
the sender and the integrity of the electronic content. We believe that 
electronic submission of registration and listing information furthers 
the purpose of this law and makes the registration and listing 
processes more efficient and effective both for industry and us.

II. Summary of Current Registration and Listing Requirements

A. Summary of Section 510 of the FD&C Act (21 U.S.C. 360)

    Section 510 of the FD&C Act contains the statutory requirements 
pertaining to device registration and listing. Section 510(b), (c), and 
(d) of the FD&C Act address registration obligations that apply to 
domestic establishments. Section 510(c) of the FD&C Act includes the 
requirement for owners or operators to immediately register their 
establishment ``upon first engaging in the manufacture, preparation, 
propagation, compounding, or processing of * * * device or devices.'' 
As clarified in section 510(a)(1) of the FD&C Act, the term 
``manufacture, preparation, propagation, compounding, or processing'' 
as used in section 510 is intended to be rather broad and also includes 
``repackaging or otherwise changing the container, wrapper, or labeling 
of any * * * device package in furtherance of the distribution of the * 
* * device from the original place of manufacture to the person who 
makes final delivery or sale to the ultimate consumer or user.''
    In addition to the initial registration requirement in section 
510(c), owners or operators of domestic device establishments are also 
required to renew their registrations on an annual basis. Prior to 
FDAAA, section 510(b) provided that such registration had to be 
completed ``[o]n or before December 31 of each year.'' FDAAA amended 
the timeframes in section 510(b) and now requires annual registration 
to be performed during the 3-month period beginning on October 1 and 
ending on December 31 of each year.
    Section 510(d) of the FD&C Act requires an owner or operator that 
has previously registered an establishment to immediately update his 
registration information on file with the agency to include any 
additional establishment that he owns or operates in which he begins 
the ``manufacture, preparation, propagation, compounding, or 
processing'' of a device or devices.
    Section 510(i) of the FD&C Act contains certain registration and 
listing requirements that specifically pertain to

[[Page 14512]]

foreign establishments. The owner or operator of a foreign 
establishment has to register and list with FDA if the establishment is 
engaged in the ``manufacture, preparation, propagation, compounding, or 
processing of * * * a device that is imported or offered for import 
into the United States.'' Section 510(i) specifies that the 
registration and listing information must be submitted to FDA by 
electronic means, and also requires the foreign establishments to 
furnish, as part of their registration, ``the name of each importer of 
[the establishment's] device in the United States that is known to the 
establishment, and the name of each person who imports or offers for 
import such * * * device to the United States for purposes of 
importation.'' Prior to the passage of FDAAA, section 510(i) required 
foreign establishments to complete their annual registration ``[o]n or 
before December 31 of each year.'' FDAAA amended the timeframes in 
section 510(i) and now requires annual registration to be performed 
during the 3-month period beginning on October 1 and ending on December 
31 of each year.
    Section 510(g) of the FD&C Act establishes specific exemptions from 
registration requirements and permits the Secretary, under section 
510(g)(5), to create additional exemptions by regulation where the 
Secretary finds that registration by those persons is not necessary for 
the protection of public health.
    Under section 510(e) of the FD&C Act, we may assign a registration 
number to any person or establishment who registers. We may also 
prescribe a uniform system for the identification of devices intended 
for human use and require that persons who are required to list their 
devices do so in accordance with such a system.
    Section 510(f) of the FD&C Act is the provision governing the 
public availability of registration and listing information that has 
been submitted to FDA in accordance with section 510.
    Section 510(j) of the FD&C Act prescribes the requirements for 
device listing. Section 510(j)(1) requires every person who registers 
to file, at the time of registration, a list of all devices that are 
being ``manufactured, prepared, propagated, compounded, or processed by 
him for commercial distribution'' and which have not been previously 
listed by him or her. Section 510(j)(1) further requires that the 
listing information be prepared and submitted in the ``form and manner 
prescribed by the Secretary.'' Section 510(j)(2) of the FD&C Act 
requires registrants to periodically update their listing information. 
Prior to the passage of FDAAA, registrants were required to update 
their device listings two times each year, once in June and once in 
December. As amended by FDAAA, section 510(j)(2) now requires device 
listing information to be updated only once each year during the period 
beginning on October 1 and ending on December 31, which is the same 3-
month period during which establishments are required to complete their 
annual registration.
    Section 510(p) of the FD&C Act, as amended by FDAAA, requires the 
electronic submission of device registration and listing information 
unless the Secretary grants a request for a waiver because use of 
electronic means is not reasonable for the person requesting the 
waiver.
    On October 8, 2009, FDA published the document ``Guidance for 
Industry and FDA Staff--Implementation of Medical Device Establishment 
Registration and Device Listing Requirements Established by the Food 
and Drug Administration Amendments Act of 2007.'' The purpose of the 
Guidance is to explain changes in the device registration and listing 
program that are required by Section 207 of the Medical Device User Fee 
and Modernization Act of 2002 and the Food and Drug Administration 
Amendments Act of 2007. Copies of the guidance can be found on the 
Internet at: http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments/ucm185871.htm.

B. Summary of Current Registration and Listing Regulations

1. Who Must Register and List Under the Current Regulations?
    Under current part 807 (21 CFR part 807) of FDA's regulations, with 
certain exceptions, owners or operators of establishments that engage 
in the manufacture, preparation, propagation, compounding, assembly, or 
processing of a device intended for human use must, in addition to 
other requirements, register their establishments and submit listing 
information for each of their devices in commercial distribution. FDA 
has interpreted the types of establishments that must register and/or 
list to include, among others, manufacturers, contract manufacturers 
and contract sterilizers (currently required to register and list only 
if they also distribute the device commercially on behalf of the party 
initiating the specifications), specification developers, 
remanufactures, repackages, re labelers, single-use device (SUD) 
preprocessors, and initial importers (these parties are currently 
required to register but need not submit listing information). Foreign 
device establishments that manufacture, prepare, propagate, compound, 
process or export a device that is imported or offered for import into 
the United States also must comply with the registration and listing 
requirements, including the requirement to identify a U.S. agent. The 
current regulations provide for all registration and listing 
information to be submitted to us using paper forms FDA 2891, 
Registration of Device Establishment; FDA 2891a, Annual Registration of 
Device Establishment; and FDA 2892, Device Listing, as required by 
Sec.  807.22.
2. What Are the Registration Requirements Under the Current 
Regulations?
    The existing regulations in part 807 contain various provisions 
governing the requirements for registration. Among others, those 
provisions include the following:
     Section 807.21(a) requires owners or operators of 
establishments entering into the manufacture, preparation, propagation, 
compounding, assembly, or processing of a device or devices to register 
their establishment within 30 days after beginning such an activity at 
their establishment.
     Sections 807.25 and 807.40 describe the information 
required to be submitted by owners or operators of domestic and foreign 
establishments as part of their registration. This information 
includes:
     The names of the registered establishment, its owner or 
operator, and its official correspondent;
     Contact information for the official correspondent;
     Trade names used by the establishment;
     The types of operations or activities conducted at the 
establishment; and
     The name and contact information for their designated U.S. 
agent (applies only to foreign establishments).
     Section 807.21(a) requires owners or operators to renew 
their establishment's registration on an annual basis in accordance 
with a schedule specified in the regulations.
     Section 807.35 provides for FDA to assign a permanent 
registration number to each establishment after reviewing the 
information provided to us on Form FDA 2891 at the time of the 
establishment's initial registration.
3. What Are the Listing Requirements Under the Current Regulations?
    The listing provisions currently found in part 807 include, among 
others, the following:

[[Page 14513]]

     Owners or operators of establishments must, at the time of 
registration, submit a list of devices being manufactured or processed 
at the establishment that are in commercial distribution at that time 
using forms) FDA 2892 (Sec.  807.21(a)).
     The device listing information required to be submitted to 
us under Sec.  807.25(f) includes, but is not limited to the 
classification name and number for the device (in practice, the product 
code assigned to the device by FDA is ordinarily provided rather than 
the classification name and number); the proprietary and common names 
associated with the device; the name and FDA-assigned identification 
number of the owner or operator; the name, registration number, and 
establishment type of all establishments under the joint ownership and 
control of the owner or operator at which the device is manufactured, 
repackaged, or re labeled; the number assigned by FDA to an approved 
application for each device listed that is subject to pre market review 
under section 505 of the FD&C Act (21 U.S.C. 355) or section 515 of the 
FD&C Act (21 U.S.C. 360e) (in practice, the owners and operators are 
also providing 510(k) clearance and Humanitarian Device Exemption (HDE) 
numbers); the reason for the submission (e.g., represents a new device 
listing, an update to an existing listing, or the device is being 
discontinued); and if the listing relates to a previously listed 
device, as in the case of an update, the initial listing number for the 
device.
     The current regulations at Sec.  807.30(b) require owners 
or operators to update their device listing information twice each year 
during June and December, or at their discretion, at the time the 
change occurs. Updated information must include, but need not be 
limited to:
     A list of each device introduced by the registrant for 
commercial distribution that has not been included in any previously-
submitted list;
     All previously-listed devices for which commercial 
distribution has been discontinued;
     A list of all devices for which a notice of discontinuance 
was submitted and for which commercial distribution has since that time 
been resumed; and
     Information about any other material change to listed 
products, as required under current Sec.  807.30(b).
4. Who Is Not Covered by Registration and Listing Requirements Under 
the Current Regulation?
    Under the current regulations, certain establishments are exempt 
from the registration and listing requirements set forth in part 807. 
Section 510(g) of the FD&C Act, which establishes certain exemptions 
from registration requirements, authorized FDA to exempt additional 
classes of persons from registration requirements by regulation when we 
determine that registration by those persons is not necessary for the 
protection of the public health. (21 U.S.C. 360(g)). These exemptions 
are reflected in our regulations at Sec.  807.65. Section 807.65 
provides an exemption from registration requirements for the following 
types of establishments:
     A manufacturer of raw materials or components;
     A manufacturer of veterinary devices;
     A manufacturer of common and widely-used laboratory 
equipment and/or chemical reagents not labeled or promoted for medical 
use; and
     Carriers whose business it is to transport and deliver 
devices.
    Section 807.65 further exempts from registration requirements the 
following types of establishments, provided they are domestic 
establishments:
     Licensed practitioners, including physicians, dentists, 
and optometrists, who manufacture or otherwise alter devices solely for 
use in their professional practice;
     Persons who manufacture, prepare, propagate, compound or 
process devices solely for use in research, teaching, or analysis, and 
do not introduce such devices into commercial distribution;
     Pharmacies, surgical supply outlets, or other similar 
retail establishments making final delivery or sale to the ultimate 
user; and
     Persons who dispense previously-manufactured devices or 
render services to the ultimate consumer (i.e., patient, physician, 
layman, etc.), such as a hearing aid dispenser, optician, clinical 
laboratory, assembler of diagnostic x-ray systems, as well as personnel 
from a hospital, clinic, dental laboratory, orthoepic or prosthetic 
retail facility whose primary responsibility to the ultimate consumer 
is to dispense or provide a service through the use of a previously 
manufactured device.
    Additionally, under current Sec.  807.20(c), establishment 
registration and device listing requirements do not apply to any person 
who:
     Manufactures the device for another party who initiated 
the specifications and distributes the device;
     Sterilizes the device on a contract basis for another 
party who distributes the device; or
     Acts only as a wholesale distributor and does not 
manufacture, repackage, process, or re label the device.
5. Do the Current Regulations Permit the Disclosure of Registration and 
Listing Information?
    Section 807.37 of the current regulations addresses the extent to 
which registration and listing information submitted to us will be 
available for public disclosure and the procedure for obtaining access 
to such information. Specifically, that provision states that all 
registration information submitted by an establishment on forms FDA 
2891 and FDA 2891a will be made available for inspection at the CDRH 
Office of Compliance in Maryland and also at the district office that 
has responsibility for that establishment. In practice, these documents 
are no longer kept at the district offices, but can still be requested 
from the Office of Compliance. Registration data also can be searched 
and downloaded from CDRH's Web site at www.fda.gov/cdrh.
    Device listing information submitted on Form FDA 2892 may also be 
requested as specified in current Sec.  807.37(b). Listing information 
can also be searched and downloaded from CDRH's Web site. The search 
and download capabilities of the Web-based database is the method of 
obtaining registration and listing data that is most often used by the 
public.

III. Highlights of the Proposed Changes to the Current Registration and 
Listing Requirements

    This proposal would modify the current registration and listing 
regulations to reflect FDAAA's mandate that device registration and 
listing be submitted electronically and to facilitate the government's 
collection of additional registration information as mandated by the 
Bioterrorism Act. It also would revise certain registration and listing 
provisions to improve the quality of registration and listing 
information that will be available to FDA for use in pursuing its 
important health objectives.

Proposed Changes to the Current Registration and Listing Regulations

    We are proposing the following changes to the current registration 
and listing regulations:
1. Switch to an Electronic Registration and Listing System
    The current regulations in part 807 require owners and operators of 
device establishments to submit their registration and listing 
information to FDA using paper forms (Forms FDA 2891, FDA 2891a, and 
FDA 2892). This proposal would update the regulations to conform to the 
requirement in section 510(p) of the FD&C Act, as amended by

[[Page 14514]]

FDAAA, that such information be provided to FDA electronically unless 
FDA grants a request for a waiver.
    As part of the new electronic registration and listing system, each 
owner or operator establish an account using the FURLS, from which the 
owner or operator creates and updates his or her establishment 
registration and device listing information. Information submitted to 
FDA prior to September 15, 2007, has already been migrated to the new 
electronic database and thus there is no need for owners or operators 
to reenter this information.
    In accordance with section 510 of the FD&C Act, as amended by 
sections 222 through 224 of FDAAA, device establishment owners and 
operators have been using FURLS to submit their establishment 
registration and device listing information electronically since the 
system became operational on October 1, 2007. In addition, in 
accordance with section 510(p), as amended by FDAAA section 224, FDA is 
granting waivers from the new electronic submission requirements only 
to those owners or operators for whom electronic registration and 
listing is not reasonable.
2. Foreign Establishment Registration and Listing Requirements of the 
Bioterrorism Act
    Before its devices will be allowed into the United States, each 
foreign establishment that is required to register must supply to FDA 
the registration information required by part 807, including the name 
and contact information for its U.S. agent. Section 321 of the 
Bioterrorism Act affected foreign establishment registration in part by 
amending section 510(i) of the FD&C Act to require, as part of an 
establishment's registration, the name of each importer of the device 
that is known to the establishment and the name of each person who 
imports or offers to import the device into the United States. This 
proposal would amend part 807 to reflect in our regulations the 
Bioterrorism Act requirement that foreign establishments whose devices 
are imported or offered for import into the United States must 
identify: (1) All importers known to the foreign establishment and (2) 
the name of each person who imports or offers to import the foreign 
establishment's device into the United States. Proposed changes to 
Sec.  807.3 also would add specific definitions for these two new 
categories of information that need to be submitted by foreign 
establishments.
    On August 29, 2006, FDA issued a proposed rule (71 FR 51276) 
relating to drugs (including certain blood products) which proposed to 
revoke exemptions from registration and listing requirements found in 
Sec. Sec.  207.40(a) and 607.40(a) (21 CFR 207.40(a) and 607.40(a)) 
relating to foreign establishments whose drug products enter a foreign 
trade zone and are then re-exported from the foreign trade zone without 
having entered U.S. commerce. The same rule also proposed to revoke 
exemptions in Sec. Sec.  207.40(b) and 607.40(b) which allow a 
component of a drug imported under section 801(d)(3) of the FD&Act (or 
a blood product imported under section 801(d)(4) of the FD&C Act) to be 
imported or offered for import into the United States even if the 
component is not listed and manufactured, prepared, propagated, 
compounded, or processed at a registered foreign establishment. (21 
U.S.C. 381(d)(3) and (d)(4)).
    Consistent with the revisions proposed to Sec. Sec.  207.40 and 
607.40, and for the reasons discussed in that rule (see 71 FR 51283-
51284 and 51324), we are proposing to eliminate the exemption in Sec.  
807.40(a) for foreign establishments whose devices enter a foreign 
trade zone and are re-exported from the foreign trade zone without 
entering U.S. commerce, and the exemption in Sec.  807.40(c) for 
devices that are imported under section 801(d)(3) of the FD&C Act (21 
U.S.C. 381(d)(3)). We believe that removing the exemptions from 
registration and listing requirements for devices entering foreign 
trade zones and for products imported under section 801(d)(3) of the 
Act is consistent with Congress' desire, as reflected in the 
Bioterrorism Act, to increase the Nation's ability to prepare for and 
effectively respond to bioterrorism and other public health emergencies 
by requiring foreign establishments to provide more, rather than less, 
information for imported products.
3. Change in Requirements Relating to Contract Manufacturers and 
Sterilizers
    The proposed regulation would amend current part 807 regarding the 
applicability of registration and listing requirements to contract 
manufacturers and contract sterilizers. Under the proposed regulation, 
all contract manufacturers and sterilizers would be required to 
register their establishment and list their devices. Currently Sec.  
807.20(a)(2) states that contract manufacturers who do not put the 
device into commercial distribution do not have to list those devices. 
In addition, Sec.  807.20(c)(1) and (c)(2) currently provide that 
contract manufacturers and sterilizers who do not put a device into 
commercial distribution do not have to register or list. These two 
provisions, taken together, have been interpreted as requiring contract 
manufacturers and sterilizers to register and list only if they 
distribute the device commercially on behalf of the person initiating 
the specifications.
    FDA relies on having a complete and accurate registration of device 
establishments and the devices processed at those establishments in 
order to accomplish a number of important statutory and regulatory 
objectives. FDA's recent experience with contract manufacturers and 
contract sterilizers since October 1, 2007, suggests that many of these 
firms that have voluntarily registered and listed in the past, no 
longer do so. When such establishments experience a problem, it can 
have significant impact on the product lines for the one or multiple 
firms for which it is contracted to provide manufacturing or 
sterilization services. Knowing which products are manufactured or 
sterilized at the affected site could facilitate the recall of the 
impacted devices. FDA also believes that knowing that these 
manufacturing sites exist would be critical information when a device 
is in short supply or needed in the event of a national emergency.
    We are proposing to modify Sec.  807.20(a)(2) and delete Sec.  
807.20(c)(1) and (c)(2) such that all contract manufacturers and 
contract sterilizers would be required to register their establishments 
and list their devices regardless of whether they put the device in 
commercial distribution.
4. Requiring Submission of the FDA Product Code Assigned to a Device 
Rather Than the Classification Name and Number
    Current Sec.  807.25(f)(1) indicates that when listing their 
devices, registrants need to provide, among other information, the 
classification name and number of each device. The new electronic 
system would require exempt devices to be identified by product code 
rather than by classification name and number. The product code is 
already requested for such devices. This change to the regulation, 
therefore, is intended to codify the existing practice.
5. Requiring Submission of the 510(k) or HDE Number for Non-Exempt 
Device Listings
    Current Sec.  807.25(f)(3) requires owners or operators to provide 
as part of their device listing information the premarket submission 
number assigned by FDA under section 505 or 515 of the FD&C Act (21 
U.S.C. 360j) for approved

[[Page 14515]]

devices. FDA also has been requesting owners or operators to identify 
as part of their device listing information the assigned premarket 
notification number for a device cleared under section 510(k) of the 
FD&C Act (i.e., the 510(k) number) or the assigned HDE number for a 
device approved for marketing under section 520(m) of the FD&C Act. 
This proposal amends Sec.  807.25(f)(3) (at proposed Sec.  
807.25(g)(4)) to include 510(k) numbers and HDE numbers among the types 
of premarket submission numbers required to be provided as part of the 
listing information submitted to FDA for non-exempt devices.
    Collection of the premarket submission numbers allows FDA to better 
protect the public health by providing a mechanism FDA can use to 
follow the total product life cycle of non-exempt medical devices. 
Having access to this information through the listing process also 
facilitates the agency's use of information that was collected during 
premarket review to identify devices by attributes other than the 
product code that is assigned to the product. This would include 
information such as whether the device contains materials from animal 
sources, is an implanted device, and other information that generally 
is not collected as part of the device listing.
    Until FDA began collecting the 510(k) number, it was difficult to 
determine which products listed under registration and listing 
requirements were being marketed under a specific premarket 
notification clearance. At times, the product code assigned to a device 
during the premarket notification clearance process was not accurately 
identified when the device was listed. This meant that a device 
assigned one product code during the 510(k) review process could 
ultimately be listed with FDA under a different product code once the 
device was put in commercial distribution.
    This lack of a direct link between products on the market and their 
premarket filings made it difficult for FDA to know which devices that 
we had cleared were being marketed, and where the devices were being 
marketed. This change would allow us to better identify, evaluate, and 
resolve potential problems with marketed devices when public health 
concerns arise.
    Proposed Sec.  807.25(g)(4) would codify the practice of including 
the 510(k) number when listing a medical device that has gone through 
premarket clearance or the approved HDE number in the electronic device 
registration and listing system. This change also would provide FDA 
with a tool to help ensure that devices that lack a required premarket 
clearance or premarket approval are not marketed.
6. Identification of a Contact Person to Administer the Electronic 
System Accounts
    Prior to the implementation of FURLS, each owner or operator 
identified an official correspondent on Forms FDA 2891 and FDA 2891a. 
The official correspondent was the only person who could supply, delete 
or change information related to a device establishment and its 
listings. As a result of the passage of FDAAA, FDA began collecting 
device registration and listing information using FURLS beginning in 
October 2007. When using FURLS, an owner or operator needs to identify 
not only an official correspondent for the establishment but also a 
contact person for the owner or operator. The contact person is the 
only person who can administer the owner or operator's user accounts in 
FURLS.
    In instances where owners or operators have only one establishment, 
they may choose the same person to serve as both the contact person for 
the user account and the official correspondent for the establishment. 
For owners or operators with multiple establishments, the contact 
person for the owner or operator may also serve as the official 
correspondent for any or all of the owner or operator's establishments. 
Alternatively, using the accounts management software for FURLS, the 
owner or operator may create subaccounts in which different official 
correspondents are identified for each establishment.
    Proper control of access to accounts and control of the ability to 
update an establishment's online information is necessary to avoid 
errors. Therefore, we are proposing that each owner or operator 
identify only one contact person within the owner or operator's 
organization who will be responsible for creating the master account in 
FURLS for the owner or operator and assigning subaccounts to each 
establishment, if needed. Once the contact person creates the master 
account and any needed subaccounts, the official correspondent can then 
use the accounts to submit the owner or operator's establishment 
registration and device listing information to FDA.
7. Establishment Operations Will Be Reported Through Device Listing
    Currently, owners or operators are required to identify the 
operations or activities that they conduct at their establishments as 
part of the registration information required on Forms FDA 2891 and FDA 
2891a and also as part of the listing information required on Form FDA 
2892. Under the proposed rule, we would require owners or operators to 
identify the operations or activities their establishments engage in 
only as part of their device listings. This is because the new 
electronic system has been designed to automatically migrate the 
information provided in the device listing to the owner or operator's 
registration, thus saving the owner or operator from having to provide 
the same information twice. Because under the new system owners or 
operators would only have to supply such information once, this change 
will save time and help avoid inconsistencies between the registration 
and listing information for a single establishment.
8. Registration Fees
    FDAAA section 212 requires that certain medical device 
establishments pay a registration user fee when they initially register 
with us and for each annual registration thereafter. Therefore, we are 
deleting the sentence at the beginning of Sec.  807.20(b) that states, 
``No registration or listing fee is required.''
9. Definition of Restricted Devices
    This proposal also would revise the definition of ``restricted 
device'' in Sec.  807.3(i) to more accurately reflect the provisions of 
the FD&C Act that provide us with authority to restrict devices.

IV. Description of the Proposed Rule

    We are proposing to amend our establishment registration and device 
listing regulations in part 807 in order to implement changes that are 
required by FDAAA, section 321 of the Bioterrorism Act, and section 207 
of MDUFMA.
    As a result, in this proposal we have revised and re-codified some 
provisions, added new provisions, and eliminated others. The following 
discussion of the proposed rule describes the new provisions we would 
add to part 807 and also the changes we would make to the existing 
provisions.

A. General

1. What Is the Purpose of the Proposed Changes to Part 807?
    Changes we are proposing to the current registration and listing 
requirements are intended to:
     Improve the accuracy and availability of postmarket 
medical device information;
     Make submission of the information required by the 
registration and listing provisions of part 807 easier and faster;
     Comply with the Bioterrorism Act and MDUFMA by 
implementing an

[[Page 14516]]

electronic registration and listing system;
     Comply with the additional information collection 
requirements of the Bioterrorism Act;
     Eliminate ambiguity and clarify requirements in the 
current device registration and listing regulations; and
     Link postmarket listing data collection with related 
premarket data by collecting premarket review numbers assigned by FDA.
2. Who Would Be Affected by the Proposed Changes to Part 807?
    The proposed changes to part 807 would impact all device 
establishments that are required to register their establishments and 
list their devices with FDA; however, the revised regulation would have 
the greatest impact on contract manufacturers, contract sterilizers, 
and foreign establishments.
    a. Contract manufacturers and sterilizers. The proposed rule would 
require that all contract manufacturers and contract sterilizers 
register their establishments and list their devices. Currently, there 
are two provisions, Sec.  807.20(a)(2) and (c), that address the 
registration and listing requirements for contract manufacturers and 
contract sterilizers. Current Sec.  807.20(a)(2) states: ``* * * person 
who only manufactures devices according to another person's 
specifications, for commercial distribution by the person initiating 
specifications, is not required to list those devices.'' Current Sec.  
807.20(c) states: ``Registration and listing requirements shall not 
pertain to any person who: (1) Manufacturers devices for another party 
who both initiated the specifications and commercially distributes the 
device; (2) sterilizes devices on a contract basis for other registered 
facilities who commercially distribute the devices. * * *''
    These two provisions, taken together have been interpreted to 
require registration and listing by contract manufacturers or contract 
sterilizers only when they are the party placing the device into 
commercial distribution. We are proposing to delete current Sec.  
807.20(c)(1) and (c)(2) and, in addition, would revise Sec.  
807.20(a)(2) in a manner consistent with section 737(13)(A) of the FD&C 
Act (21 U.S.C. 379i(13)(A)), a provision added by FDAAA that addresses 
which types of establishments are subject to device registration user 
fees. These changes to Sec.  807.20(a) and (c) will have the effect of 
requiring all contract manufacturers and sterilizers to register and 
list regardless of whether they commercially distribute the devices. 
The agency believes this approach to registration and listing for these 
devices and combination products best enables effective oversight by 
appropriate agency components. Having all contract manufacturers and 
sterilizers register and list would provide us with basic information 
about the entities that make and clean devices. This information would 
allow us to respond in a more timely and effective fashion in the case 
of an adverse event, shortage, or other problem associated with one of 
these establishments. The information would also assist us in our 
fundamental regulatory activities, such as planning and scheduling 
inspections.
    We recognize that with regard to combination products, this 
approach to registration and listing may result in registration of the 
same facility and listing of the same product with more than one agency 
component. However, we also note the agency is currently working to 
develop harmonized electronic registration and listing systems within 
FDA. We anticipate that once these harmonized systems are in place, the 
agency will be able implement a more streamlined approach to facility 
registration and product listing for combination products.
    (b) Foreign establishments engaged in the manufacture, preparation, 
propagation, compounding, or processing of a device that is imported or 
offered for import into the United States are currently required to 
register and to submit listing information in accordance with section 
510 of the FD&C Act and Sec.  807.40 of our regulations. These foreign 
establishments are also required to designate a U.S. agent, and to 
provide contact information for that person to FDA.
    The revised regulation will codify requirements established by 
section 222 of FDAAA, which changed the timeframes in section 510(i) of 
the FD&C Act for annual registration by foreign device establishments 
to a specific 3-month period each year beginning on October 1 and 
ending on December 31. It also would codify in part 807 certain 
requirements established by section 321 of the Bioterrorism Act. The 
Bioterrorism Act amended section 510(i) of the FD&C Act to require 
those foreign establishments that have to register with FDA to do so by 
electronic means, and to include additional pieces of information as 
part of their registration. The additional information required by 
section 510(i) includes the name of each ``importer of such * * * 
device in the United States that is known to the establishment,'' and 
the name of each ``person who imports or offers for import such * * * 
device to the United States for purposes of importation.'' As discussed 
at section IV.A.4 of this document, this proposal also would 
incorporate, at Sec.  807.3, definitions clarifying these two new 
categories of information that need to be submitted by foreign 
establishments.
    Most of the provisions in section 321 of the Bioterrorism Act 
became effective on December 8, 2002, but the effective date of the 
electronic registration requirement was later delayed by MDUFMA section 
207 (which added section 510(p) of the FD&C Act) so that FDA would have 
an opportunity to put systems in place to accommodate the electronic 
receipt of registration information. The agency has now developed a 
system, FURLS, which became operational on October 1, 2007, that makes 
the electronic receipt of device establishment registration and device 
listing information feasible.
3. Who Would Be Exempt From Registration and Listing?
    We propose no changes to the categories of persons or 
establishments that are exempt from registration requirements under 
Sec.  807.65. As discussed in section IV.A.2.a. of this document, 
however, we are proposing to eliminate the exemption from listing 
requirements for contract manufacturers under Sec.  807.20(a), and the 
exemption from registration and listing requirements for contract 
manufacturers and contract sterilizers under Sec.  807.20(c)(1) and 
(c)(2). As a result, all contract manufacturers and sterilizers would 
need to register and list regardless of whether they put the devices 
into commercial distribution.
    For the same reasons as stated in the proposed revisions to part 
207 of FDA's regulations addressing drug establishment registration and 
listing, which were published in the Federal Register of August 29, 
2006 (71 FR 51276), we are proposing to revoke exemptions in current 
Sec.  807.40(a) relating to foreign establishments whose devices enter 
a foreign trade zone and are re-exported from that foreign trade zone 
without having entered U.S. commerce, and in Sec.  807.40(c) regarding 
devices that are imported into the United States under section 
801(d)(3) of the FD&C Act for further processing and then exported 
without having been placed on the U.S. market. We propose eliminating 
these two exemptions because of certain statutory changes that have 
occurred since the publication of the final rule on foreign 
establishment registration and listing. Those changes include enactment 
of the Bioterrorism Act, which reflects Congress' desire to

[[Page 14517]]

increase the nation's ability to prepare for and respond effectively to 
bioterrorism and other public health emergencies and Congressional 
findings that greater controls over imported products be part of that 
effort.
4. What Definitions and Interpretations of Terms Would Apply to Part 
807?
    In proposed Sec.  807.3, we set forth new definitions and 
interpretations of terms as follows:
    a. We are proposing to add a definition for the term Product Code 
at Sec.  807.3(k) to help describe the identifying information that 
would have to be submitted when listing a medical device that is exempt 
from premarket notification requirements. Currently, the product code 
is a three-letter code used by FDA to identify the generic category of 
a device. Section 807.25(f)(1) of our regulations currently states that 
the owner or operator must identify the classification name and number 
when providing device listing information. In practice, however, CDRH 
instead has requested and accepted the three-letter product code which 
can be identified from the Web-based medical device classification 
database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/
classification.cfm.
    b. Proposed Sec.  807.3(v) includes a definition for FURLS, which 
as stated previously, stands for FDA Unified Registration and Listing 
System. FURLS is the Internet-based electronic system that owners and 
operators of device establishments must use to submit device 
registration and listing information to FDA.
    c. As described more fully in section IV.B.3 of this document, this 
proposal would help to implement the requirement in section 510(i) of 
the FD&C Act, as amended by the Bioterrorism Act, that a foreign 
establishment engaged in the manufacture, preparation, propagation, 
compounding, or processing of a device that is imported or offered for 
import into the United States provide as part of its registration with 
FDA identifying information for each importer of such device that is 
known to the establishment. In proposed Sec.  807.3(x), we are 
proposing to define the term ``importer'' to mean a company or 
individual in the United States that is an owner, consignee, or 
recipient of the foreign establishment's device that is imported into 
the United States. We recognize that a foreign establishment may have 
more than one ``importer'' and we are proposing to include in this term 
any owner, consignee, or recipient, even if not the initial owner, 
consignee, or recipient, of the foreign establishment's device that is 
imported into the United States. Under this proposal, the term 
``importer'' would not include the consumer or patient who ultimately 
purchases, receives, or is the end user of the device, unless the 
foreign establishment ships the device directly to the consumer or 
patient. We invite comments on our definition of importer, including 
the scope of the entities included in the definition.
    d. Section 510(i) of the FD&C Act, as amended by the Bioterrorism 
Act, also requires that foreign establishments who are required to 
register with FDA identify as part of their registration information 
each ``person who imports or offers for import'' the establishments' 
devices to the United States. This requirement, which would be 
implemented at proposed Sec.  807.41, is discussed further in section 
IV.B.3 of this document. In addition, we are proposing a separate 
definition for the term ``person who imports or offers for import'' at 
Sec.  807.3(y). As defined, this term would include an agent, broker, 
or other entity, that the foreign establishment uses to facilitate the 
importation of its device into the United States. However, consistent 
with the legislative history of the Bioterrorism Act, the term ``person 
who imports or offers for import'' would not include carriers. We 
invite comments on our proposed definition of the term ``person who 
imports or offers for import.''

B. Registration

1. Who Would Be Required To Register?
    Section 510(b) of the FD&C Act states that registration 
requirements apply to owners and operators of establishments engaged in 
the ``manufacture, preparation, propagation, compounding, or processing 
of medical devices.'' Section 510(a)(1) of the FD&C Act defines these 
terms to include ``repackaging or otherwise changing the container, 
wrapper or labeling of any device package in furtherance of the 
distribution of the device * * *''.
    The revisions we are proposing would not change the classes of 
persons required to register, except to specify that all contract 
manufacturers and sterilizers must register their establishments, 
regardless of whether they put the device in commercial distribution or 
instead return it to the specification developer or point of origin.
2. When Would Initial Registration Information Need to Be Provided?
    Section 807.21, the provision specifying timeframes for 
establishment registration, is being renumbered in this proposal to 
Sec.  807.22. Proposed Sec.  807.22 would retain the requirement that 
owners or operators must register each establishment no later than 30 
calendar days after entering into an activity that triggers 
registration requirements under part 807.
    Under current Sec.  807.40(c), with certain limited exceptions, a 
foreign owner or operator must register an establishment before a 
device manufactured at the establishment may be imported or offered for 
import into the United States. This proposal would not change the 
timeframe for initial registration by a foreign establishment.
3. What Information Would Be Required for Registration?
    Under proposed Sec.  807.25, all owners or operators would need to 
provide the following information in order to register their 
establishments:
    a. Name of the owner or operator of each establishment. Section 
807.3(f) defines the owner or operator as the corporation, subsidiary, 
affiliated company, partnership, or proprietor directly responsible for 
the activities of the registering establishment. While the requirement 
to identify the owner or operator of the establishment is not new, we 
are addressing it here to provide assistance in identifying the owner 
or operator for medical device registration and listing purposes.
    In practice, the owner or operator usually is the entity that has 
final responsibility over the device establishment, such as the 
establishment's parent company or corporate headquarters. For most 
small device manufacturers who conduct their business activities at the 
same site as their regulated device activities, this typically is the 
same name and address as that of the registered establishment itself. 
In other words, for a business that has only one location where all 
medical device production activities are conducted and where corporate 
responsibility for those activities resides, the owner or operator name 
and address information is the same as the establishment information.
    This has often been a source of confusion regarding the information 
that must be submitted for registration and listing. We invite comments 
and questions about what constitutes the ``owner or operator'' of a 
device establishment for purposes of part 807.
    b. Name, trade name(s), and address of each establishment (proposed 
Sec.  807.25(b)). This provision is consistent with section 510(c) of 
the FD&C Act, which requires owners and operators to register the names 
and place of business of the establishment. There are no

[[Page 14518]]

changes being proposed to this requirement in the revised regulation.
    c. Registration number of each establishment. Section 510(e) of the 
FD&C Act authorizes us to assign a registration number to any person or 
establishment who registers. Under Sec.  807.35(a) of our regulations, 
we currently assign a permanent registration number to each device 
establishment when that establishment registers for the first time. The 
proposed regulation would only change the method of delivery of the FDA 
registration number to the owner or operator. FDA registration numbers 
are communicated to the registrant by email after we receive the 
registration information through the electronic device registration and 
listing system and it has been verified by the appropriate FDA district 
office. As there is no physical document to validate and return, FDA no 
longer sends a validated copy of a form back to the registrant by 
postal mail.
    d. Name, address, telephone and fax numbers, and e-mail address of 
the official correspondent for each establishment (proposed Sec.  
807.25(e)). In this document, we continue to require information 
regarding the official correspondent of the establishment because we 
need a contact person to be responsible for submitting and keeping the 
establishment's registration and device listing information current, 
and to facilitate contact between FDA and the owner or operator. Under 
proposed Sec.  807.25(e), this information must be kept current and any 
change in this information must be provided to us within 30 calendar 
days.
    e. Information for foreign establishments only. With respect to 
foreign establishments who are required to register their establishment 
with FDA, we would require under proposed Sec. Sec.  807.40 and 807.41, 
that such establishments submit the name, address, telephone and fax 
numbers, and e-mail address for the following:
     The U.S. agent;
     Each importer of the establishment's device in the United 
States that is known to the establishment; and
     Each person who imports or offers for import the 
establishment's device to the United States.
    The name, address, and phone number of the United States agent is 
information that already must be submitted under current Sec.  
807.40(c). We are proposing that owners or operators also be required 
to provide information regarding importers and persons who import or 
offer for import the foreign establishment's device because of changes 
made to section 510(i) of the FD&C Act by section 321 of the 
Bioterrorism Act. Section 510(i), as amended, requires foreign 
establishments to submit as part of their annual registration, among 
other things, the name of each ``importer'' of their device that is 
known to the foreign establishment and also the name of each ``person 
who imports or offers for import'' the foreign establishment's device 
to the United States. We, therefore, expect the person responsible for 
providing the registration and listing information on behalf of the 
foreign establishment to undertake appropriate due diligence in 
gathering and entering the information, which would include identifying 
and reporting those importers that others in his or her establishment 
know of or have reason to know of. In addition to identifying them by 
name, the proposal would require that the foreign establishment provide 
the address, telephone and fax numbers, and e-mail address of each 
importer and each person who imports or offers for import to enable us 
to contact these persons.
    We expect that some of the foreign establishments' ``importers'' 
will be parties who also are considered ``initial importers'' as that 
term is defined in our current registration and listing regulations at 
Sec.  807.3(g). Under Sec.  807.3(g), the term initial importer means 
any importer who furthers the marketing of a device from a foreign 
manufacturer to the person who makes the final delivery or sale of the 
device to the ultimate consumer or user, but does not repackage, or 
otherwise change the wrapper or labeling of the device of device 
package. Because initial importers are already required to register, 
the electronic registration and listing system will permit foreign 
establishments to use a search mechanism built into the system to 
identify those importers of the foreign establishment's devices that 
are also initial importers. Foreign establishments providing 
information for other types of importers such as retail establishments 
and end users who are not ordinarily required to register with FDA 
would have to provide the name, address and contact information for 
each such importer, except they would not need to identify an end user 
that is either a consumer or patient, unless the foreign establishment 
ships its product directly to the consumer or patient.
    Because foreign establishments may use different importers and 
persons who import or offer for import for different devices, in order 
to collect this information efficiently, the agency proposes to have 
foreign establishments provide this information when they are listing 
their devices. The electronic system will provide an interface for the 
foreign establishment to identify each product's importers and persons 
who import or offer for import on a listing-by-listing basis.
    The foreign establishment would not be considered registered until 
all information required under proposed Sec. Sec.  807.25, 807.40 and 
807.41 is submitted. Foreign establishment registration data collected 
through the electronic registration and listing system will allow us to 
accurately identify who is making devices, where they are being made, 
and where they are going within the United States. Having this 
information is critically important to the nation's ability to prepare 
for and effectively respond to public health emergencies, including 
bioterrorism threats and other public health emergencies.
    4. What Are the Proposed Requirements for Reviewing and Updating 
Registration Information?
    This proposal would modify and streamline the requirements 
associated with updating registration information. Currently, the 
regulations require that owners or operators submit changes to their 
establishment registration information on Form FDA 2891a at the time of 
annual registration, or by letter if the changes occur at other times. 
Under proposed Sec.  807.22, establishments would access FURLS and 
review their current registration information online, making changes 
only where needed. Updating registration information is less time 
consuming using FURLS because the establishment's current information 
is easily accessible at all times and only changes to the information 
already in the system need to be entered into the applicable fields. 
Previously, the registration and listing forms required that most or 
all of an establishment's registration and/or device listing 
information be re-entered on each paper form submitted to FDA.
    Some of the specific requirements proposed for updating 
registration information include the following:
    a. Updates of registration information. Owners or operators, under 
proposed Sec.  807.25, would report the following changes no later than 
30 calendar days after the change occurs:
     The closing or sale of an establishment;
     Any change in the name or address of an establishment;
     Any change in the name or address of the owner or 
operator; and
     Any change in the name, address, telephone and fax 
numbers, or e-mail

[[Page 14519]]

address of the official correspondent or the U.S. agent.
    We encourage establishments to provide expedited updates as soon as 
possible after the change occurs, which the new electronic device 
registration and listing system will facilitate, but no later than 30 
calendar days after the change occurs.
    b. Annual review and update of registration information. Proposed 
Sec.  807.22 would require that registration information be reviewed 
and updated annually, during the period beginning on October 1 and 
ending on December 31, which represents the first 3 months of FDA's 
fiscal year. This timeframe is consistent with the requirements in 
section 510(b) and (i) of the FD&C Act as amended by section 222 of 
FDAAA. Current Sec.  807.21 provides a schedule for the annual 
registration of establishments during one of four periods of the 
calendar year (i.e., March, June, August, and November) based on the 
first letter of the owner or operator's name. Proposed Sec.  807.22 
would replace this schedule with the requirement that all owners or 
operators renew their registration information annually, during the 
period beginning on October 1 and ending on December 31 of the fiscal 
year for which they are registering.
    All registration information would need to be reviewed and updated 
each year using FURLS, even when no changes have occurred during the 
previous year. The phrase ``review and update'' as used in proposed 
Sec.  807.22(b) stresses the importance of first reviewing all 
registration information to determine if any changes have occurred, and 
then updating the information where needed, or confirming the accuracy 
of the current information. Under proposed Sec.  807.22, updates must 
reflect all changes that have occurred since the last update.
    When an owner or operator fails to comply with the annual 
registration or listing requirements, the establishment converts to a 
``failed to register'' or ``failed to list'' status as applicable. This 
would include registrants who have not been granted a waiver from 
electronic registration who attempt to re-register their establishment 
by submitting a paper-based form or letter. These establishments would 
retain their failed to register and/or list status until the owner or 
operator uses the electronic system to review, update, and certify the 
accuracy of their registration and listing information.
    We believe that placing establishments whose owners or operators 
fail to comply with registration or listing requirements in one or both 
of these categories, as applicable, is reasonable given the importance 
of registration and listing information. To increase the nation's 
ability to prepare for and respond effectively to public health 
emergencies, including bioterrorism threats and other public health 
emergencies, it is becoming increasingly important for owners and 
operators of device establishments to comply with our registration and 
listing requirements. With accurate registration and listing 
information, FDA can more quickly identify where particular types of 
devices, e.g., respirators or blood tubing, are being made and help 
ensure that they are available as promptly as possible for a public 
health emergency. Furthermore, taking steps to increase compliance with 
these requirements is consistent with section 301(p) of the FD&C Act 
(21 U.S.C. 331(p)), which makes it a prohibited act to fail to register 
or list in accordance with section 510 of the FD&C Act.
    c. Type of operation. We are proposing to have owners or operators 
enter information about the types of operations or activities conducted 
at each of their establishments only when they are entering listing 
information. Before the implementation of FURLS, changing the types of 
operations or activities required updates to both registration and 
listing data. This has in some instances led to discrepancies between 
the types of activities being reported on an establishment's 
registration forms as compared to the activities being reported on 
their device listing forms.
    FURLS automatically keeps an establishment's registration record 
current and consistent with its listing information by assigning or 
removing activities to and from the registration record based on the 
current active listing information for each device. This practice will 
help to avoid confusion and conflicts between registration and listing 
information for a single establishment.
    d. How the information would be submitted. Proposed Sec.  807.21 
would require establishments to submit information to us 
electronically, unless we grant a waiver under proposed Sec.  
807.21(b).
    e. Transfer of device establishment ownership. Under this proposal, 
information regarding changes to ownership of device establishments 
would also be submitted using the electronic device registration and 
listing system. There would be a selection from the main menu that will 
appear for the device registration and listing system when accessed 
through FURLS that will prompt the user through the process of 
submitting all information required to report the transfer of 
ownership.

C. Listing

1. Who Would Be Required to List Devices?
    The changes we are proposing would not change the classes of 
persons that are required to list devices, except to alter the listing 
obligations of those contract manufacturers and sterilizers who are 
currently exempt from listing under Sec.  807.20(a)(2), (c)(1), and 
(c)(2) because the establishments for whom they make or sterilize 
devices on a contract basis are the ones who commercially distribute 
the devices. As stated elsewhere in this document, we are proposing to 
eliminate this exemption, which will have the effect of requiring all 
contract manufacturers and contract sterilizers to register and list 
regardless of who has responsibility for placing the devices into 
commercial distribution.
    Under this proposal, all parties who are required to register would 
continue to be required to also provide device listings to FDA, with 
the exception of initial importers. Initial importers currently are not 
required to submit a device listing for those devices for which the 
initial importer did not initiate or develop the specifications, or 
repackage or relabel the device. We are not proposing to change this 
practice.
2. When Would Listing Information Be Provided?
    Under proposed Sec.  807.22(a), at the time an establishment is 
initially registered, owners and operators would list any device that 
the establishment manufactures or otherwise puts in commercial 
distribution. This provision is consistent with section 510(j)(1) of 
the FD&C Act, which requires, among other things, that every person who 
registers with the Secretary under section 510(b), (c), (d), or (i) of 
the FD&C Act must, at that time, provide the Secretary with a list of 
the devices being manufactured, prepared, propagated, compounded, or 
processed by that person for commercial distribution.
    Proposed Sec.  807.22(a) and (b) also address providing listing 
information for devices not previously listed and reviewing and 
updating information for devices that have already been listed. 
Previously, owners or operators were required to review and update 
listing information each June and December and submit all material 
changes to the device listing information that had been previously 
submitted.

[[Page 14520]]

    Although registrants may choose to amend their device listing 
information at any time throughout the year, under proposed Sec.  
807.22(a) and (b), owners and operators would be required to review and 
update their listing information only once per year, during the annual 
registration period beginning on October 1 and ending on December 31 of 
each year. In addition, foreign establishments would continue to be 
required to submit device listings before their devices may be imported 
or offered for import into the United States.
3. What Listing Information Would Be Required?
    The following discussion summarizes the new information that would 
be required under proposed Sec. Sec.  807.25, 807.26, and 807.28:
    a. The assigned FDA premarket submission number of the approved 
application or cleared premarket notification for each device listed 
that is subject to sections 505, 510, 515, or 520 of the FD&C Act, 
which includes devices that are not exempt from premarket notification 
and approval. In the case of non-exempt products, owners or operators 
would be required to identify a product's premarket submission number, 
that is, the number FDA assigned to the 510(k), premarket approval 
(PMA) application, product development protocol (PDP), humanitarian 
device exemption (HDE), or new drug application (NDA). Unlike the 
previous system, which assigned one listing per product code, under the 
new electronic system (FURLS) each device with a premarket submission 
number now constitutes a separate listing and is assigned a unique 
listing number. In FURLS, when the premarket submission number is 
entered, the product codes that were assigned to the premarket 
submission based on the FDA premarket review are automatically 
displayed. This new system helps establishments ensure that the listed 
product codes match those that appear on the substantial equivalence 
notification or on the premarket approval letter.
    This change, which would be codified in Sec.  807.25(g)(4), 
generates more unique listing numbers than the previous system, because 
individual listings are generated for each product subject to a 510(k), 
PMA, PDP, HDE, or NDA.
    b. Additional types of information required to be provided by 
foreign establishments. With respect to foreign establishments only, 
for devices manufactured, prepared, propagated, compounded, or 
processed at the establishment, the establishment must identify and 
provide contact information for: (1) The U.S. agent, (2) each importer 
of the foreign establishment's device in the United States that is 
known to the establishment (``importers''), and (3) each person who 
imports or offers for import such device to the United States. The 
requirement for foreign establishments to designate a U.S. agent is 
already included in the current regulations at Sec.  807.40(b) and this 
requirement would not change. However, the information regarding 
importers and persons who import or offer for import currently is not 
required to be submitted under part 807. Because section 321 of the 
Bioterrorism Act requires the submission of information about importers 
and persons who import or offer for import, we are proposing to amend 
our regulations to conform to the statutory requirements.
    In order to make it easier for foreign establishments to provide 
information about importers and persons who import or offer for import 
when they are registering and listing with FDA, FURLS includes an 
interface that allows the foreign establishments to select their 
importers from the FDA database of registered initial importers, and to 
enter the names, addresses, and other contact information for any 
additional importers and persons who import or offer for import (e.g., 
agents, brokers) who have not previously been entered into the 
electronic database.
    Several of the listing requirements in current Sec. Sec.  807.25, 
807.26, and 807.28 have changed only insofar as how the information 
would be submitted using FURLS. These requirements include the 
following:
    c. The current registration number and name of each establishment 
under the ownership and control of the owner or operator that performs 
a regulated function to a device. Proposed Sec.  807.25(g)(1) requires 
that the owner or operator provide FDA with the registration number(s) 
for all establishments under his or her ownership or control that 
perform a regulated function on, to, or for a device. This means the 
owner or operator does not need to inform FDA of any activity regarding 
the device that is performed at an establishment that is not under the 
owner or operator's ownership or control. For example, an owner or 
operator that develops specifications at one establishment that is 
under its ownership and control, and then manufacturers the device at 
another establishment that is also under its ownership and control, 
must inform FDA about both establishments when listing the device. 
However, an owner or operator that develops specifications for a device 
that is then manufactured by another owner or operator's establishment, 
i.e., an establishment which is not under its ownership and control, 
must only identify the establishment where the specifications were 
developed, when submitting listing information. In this case, the owner 
or operator would not need to identify the manufacturing establishment.
    This requirement, while not new, has in the past been the source of 
some confusion. To avoid further confusion, FURLS has been designed 
such that an owner or operator can only submit listing information for 
establishments under its ownership or control. Under FURLS, the owner 
or operator selects their establishment(s) from a pick list that only 
includes establishments under the owner or operator's control.
    d. The product code for all listed devices that are exempt from 
premarket notification and approval, as well as devices put into 
commercial distribution prior to May 28, 1976. Under this proposal, 
owners or operators listing devices that are considered exempt from 
premarket notification, ``pre-amendment'' devices, (i.e., devices put 
into commercial distribution prior to May 28, 1976), or devices 
intended for export only, would continue to identify an applicable 
product code for the device at the time of listing. When submitting 
listing information using Form FDA 2892, the owner or operator had to 
make the determination of which products could be listed under their 
product code and did not require an FDA premarket submission number. 
However, the new electronic system automatically displays only the 
product codes for which an owner or operator can create an exempt or 
export-only listing during the listing process, thereby eliminating the 
possibility of the owner or operator selecting a product code that 
requires a premarket submission.
    e. The proprietary or brand name(s) under which the device is 
marketed. FURLS accommodates entry of as many proprietary or brand 
names as are needed for all listings. This is a change from the paper-
based system which limited the number of characters available for entry 
of the proprietary or brand names. The design of the FURLS database and 
Web interface allows entry of as many proprietary or brand names as may 
be associated with the listing.
    f. Each activity or process that is conducted on, or done to, the 
device by the listing owner or operator at each establishment shown on 
the listing, such as manufacturing, manufacturing for export only, 
repacking, relabeling,

[[Page 14521]]

developing specifications, remanufacturing, SUD reprocessing, contract 
manufacturing, or contract sterilizing. We are proposing that 
information about the activities or processes that are performed with 
respect to a device at each registered establishment such as 
manufacturing, manufacturing for export only, repacking, relabeling, 
developing specifications, remanufacturing, single-use device 
reprocessing, contract manufacturing, or contract sterilizing, be 
identified as a part of the listing process only. Previously, we 
required such information to be submitted on the establishment 
registration form (under ``Establishment Types'') and on the device 
listing form. Consequently, at times there were inconsistencies between 
the two forms, which led to confusion about the activities actually 
being conducted at a particular device establishment at any given time, 
especially as companies added new products or discontinued previously-
listed products. By limiting the submission of this information to the 
listing process, the information available to FDA should become more 
consistent and accurate because FURLS is designed to automatically 
conform the establishment registration record to reflect any changes 
made to the device listing information, including any changes in the 
types of activities or processes performed at the establishment. For 
example, if an owner or operator lists a product under product code ABC 
as being manufactured at Establishment 1, and lists another product 
under product code DEF as being repacked or relabeled at Establishment 
1, then Establishment 1's registration would automatically include 
manufacturing and repacking/relabeling as activities at the 
establishment. If the owner or operator were to amend its listing 
information to reflect that it discontinued the product under product 
code DEF, the registration data for Establishment 1 would automatically 
be revised to show Establishment 1 as a manufacturing site only.
    We expect this will be a more efficient way to collect this 
information, and should lessen the burden on the owner or operator, who 
no longer would be required to enter information about the 
establishment's operations during both the registration and the listing 
processes. The owner or operator would no longer be responsible for 
ensuring that the activities identified in their registration record 
are consistent with those in their listing records because changes made 
to the activities included on their listing records would automatically 
update the activities on their registration record.
4. What Are the Proposed Requirements for Reviewing and Updating 
Listing Information?
    Previously, establishments had to enter new or revised listing 
information on Form FDA 2892 and return the form to FDA. Under this 
proposal, owners or operators would instead be required to access our 
electronic device registration and listing system (FURLS), review their 
current listing information online, and make any changes as needed. 
Updating listing information is less time-consuming under the proposal 
because owners or operators are able to access their information at any 
time, and only need to enter data in the fields where there are changes 
to listing information. It also eliminates the need to mail the form to 
FDA, and eliminates the return and re-mailing of listing forms when the 
information initially provided on the form was incorrect or incomplete. 
The electronic system has automatic validations and edits built in to 
help ensure that all listing information is complete and correct.
    Under proposed Sec.  807.22(b), during the annual review and update 
of registration information, establishments would be required to 
provide original listing information for any device that has not been 
previously listed, as well as updates to listings for devices that have 
been previously listed.
    Under proposed Sec.  807.22(b)(3), owners or operators would review 
and update their listing information during the period beginning on 
October 1 and ending on December 31 of each year. This is consistent 
with the timeframes set forth in the amendments to section 510(j)(2) of 
the FD&C Act by section 223 of FDAAA.

D. Electronic Format

1. How Would Registration and Listing Information Be Provided To FDA?
    Under proposed Sec.  807.21, all registration and listing 
information would be provided to FDA through use of our electronic 
device registration and listing system, FURLS, with the exception of 
labeling and advertisement information for a device (when submission of 
this information is appropriate), and information from those owners and 
operators who are granted a waiver from the requirement to submit 
information electronically.
    To register their establishment and list their devices using FURLS, 
owners or operators need to do the following:
     Create an account in the FURLS. If owners or operators 
already have a FURLS account as a food or drug establishment, they 
would update their existing FURLS account to include access to the 
device registration and listing system;
     Create subaccounts, as necessary, for the official 
correspondent for each establishment that is being registered;
     Follow the prompts and the help text provided to enter 
their establishment registration and device listing information; and
     Certify that the information entered is accurate and 
complete.
    Electronic submission of registration and listing information 
provides a number of advantages over the paper-based submission 
process. For example:
     We receive more accurate information than with paper 
submissions. The information received is more consistent and accurate 
because FURLS includes validation and automated edits to help provide 
consistency among the data. This also helps eliminate errors of 
transcription made when we input paper-based data into our old 
registration and listing database;
     Both for industry and FDA, electronic transmission of the 
information is easier and more efficient than the use of paper forms. 
For example, users submitting information receive onscreen, real-time 
feedback if the information submitted is incomplete, thereby reducing 
errors and the time and cost of communicating with FDA. Electronic 
transmission of the information also significantly reduces the time and 
cost associated with processing paper forms and communicating with 
industry about errors found on those forms; and
     The registration and listing information available for 
search and retrieval, both for FDA and industry, is more accurate and 
up-to-date. Updates may be made to FURLS in real time as opposed to the 
paper-based system where submissions could take several weeks to arrive 
at FDA from foreign establishments, then require another week to 10 
days to be screened at our mail facility, forwarded to our data entry 
contractor, and entered in our current database.
2. How Does the Electronic Device Registration and Listing System Work?
    Information that is required from owners and operators is submitted 
to our electronic device registration and listing system (FURLS) over 
the Internet. The system has a number of features designed to improve 
the overall accuracy and verifiability of submitted information, and 
decrease the burden on owners and operators to comply with

[[Page 14522]]

FDA's registration and listing regulations. The system is consistent 
with conventions found on other government sites. Some key features of 
the system are: (1) Our electronic device registration and listing 
system (FURLS) is accessible through our FDA Internet site. To use the 
Web site, you need access to the Internet using a browser. You could 
arrange for Internet access through one of many available Internet 
Service Providers (ISPs).You need an e-mail address so we can send you 
confirmation of submissions and other related information. This e-mail 
address could be obtained through the ISP or from other sources; (2) 
prior to accepting registration and listing information from this 
online system, we authenticate the source (that is, the owner or 
operator) providing the data. We authenticate entry into the electronic 
device registration and listing system by establishing user accounts 
based on current registration information. We also contacted owners or 
operators of currently registered establishments to identify the single 
contact person who is responsible for creating and maintaining the 
owner or operator's account and creating and maintaining any 
subaccounts that the owner or operator may require for additional 
official correspondents if more than one establishment is owned or 
operated by a single entity; and (3) to register and list 
electronically and to provide updates to your registration and listing 
information you would go to our Web site and follow the instructional 
prompts. You sign onto the system by entering the account number, user 
name, and password obtained by following the procedures on the FDA Web 
site and e-mailed and paper-mailed to all current owners or operators 
describing our electronic device registration and listing system. You 
are prompted to provide general information about the owner or operator 
and then specific information about each establishment and device as 
described in the provisions of proposed part 807. When all of the 
required information has been provided, the official correspondent is 
notified electronically that FDA has received the information.
3. Will FDA Provide Training on How to Submit Registration and Listing 
Information Electronically?
    We provide detailed instructions on our Web-sent e-mail and paper 
mailings to registered establishments explaining FURLS. These materials 
explain the electronic process for providing registration and listing 
information, including step-by-step instructions on creating user 
accounts and entering the information that is required under proposed 
part 807.
4. What Language Would Be Used to Provide Registration and Listing 
Information?
    All domestic firms already submit registration to us in English 
and, in this proposal, we would retain the current requirement under 
Sec.  807.40(c) that foreign establishments also submit their 
registration and listing information in the English language. While the 
requirement has not changed, it has been renumbered as Sec.  807.40(d) 
to accommodate the revisions to part 807 as described in this document.
5. Could the Electronic Format Requirements Be Waived?
    Section 510(p) of the FD&C Act, as amended by FDAAA section 224, 
requires the electronic submission of registration and listing 
information unless we grant a request for a waiver because the use of 
electronic means is not reasonable for the person requesting the 
waiver. Consistent with section 510(p), proposed Sec.  807.21(b) would 
permit establishments to request waivers from the new electronic 
submission requirements.
    We do not anticipate many waiver requests because the business 
expenses associated with owning a personal computer, obtaining an e-
mail address, and subscribing to Internet access are low. During the 
first 3 months of operation of the Web-based system, i.e, October 
through December 2007, we received fewer than 10 requests for waivers 
from the requirement to submit registration and listing data 
electronically. As we received data electronically for more than 16,000 
establishments for that same period, the waiver requests amount to less 
than one-tenth of 1 percent of the total number of establishments that 
have responded.
    Under proposed Sec.  807.21(b), we may grant a waiver request upon 
a showing that use of the Internet to access our Web-based registration 
and listing system is not reasonable for the person requesting the 
waiver. This is consistent with the requirement described in section 
510(p) of the FD&C Act, as amended by section 224 of FDAAA. Under 
proposed Sec.  807.21(b), the waiver request must explain why use of 
the Internet and our electronic registration and listing system is not 
reasonable for the requestor and must include a telephone number and 
mailing address where we can contact the person making the request. 
This information is necessary to contact the requestor and for FDA to 
determine whether a waiver can be granted. It should be noted, however, 
that waiver requests stating that it is not possible for the owner or 
operator to own a computer will probably not be granted since there are 
other ways to access the Internet. For example, most public libraries 
have computers with Internet access that can be used, often free of 
charge, by members of the public.
    In those instances when we do grant a request for a waiver, we plan 
to provide information at that time regarding how the requestor should 
submit its registration and listing information.

E. Miscellaneous

1. What Are the Proposed Requirements for an Official Correspondent and 
a U.S. Agent?
    Under proposed Sec.  807.25(e) owners or operators that are subject 
to the registration requirements in proposed part 807 would continue to 
have to designate an official correspondent for each establishment. The 
official correspondent would be responsible for:
     Entering and updating all registration and listing 
information for the establishment in the electronic system or, if the 
owner or operator has been granted a waiver from using the electronic 
system, providing all registration and listing information for the 
establishment to FDA via postal mail;
     Serving as the point of contact with FDA on matters 
relating to the annual registration of the establishment and all 
updates of registration information;
     Serving as the point of contact with FDA on matters 
relating to initial device listings and device listing updates, 
including discontinuances;
     Maintaining a current list of officers and directors for 
submission to FDA upon FDA's request; and
     The receipt of pertinent correspondence from FDA directed 
to and involving the owner or operator and/or any of the owner or 
operator's establishments. Under proposed Sec.  807.25(e), we are also 
adding the requirement that each owner or operator provide FDA with the 
name of a contact person at the owner or operator's offices who will be 
responsible for identifying the official correspondent for each 
establishment. The owner or operator contact person will be the 
official correspondent in the event no one else has been properly 
designated. The contact person would be responsible for establishing 
and updating the owner or operator's electronic registration and

[[Page 14523]]

listing accounts and all subaccounts that may be necessary.
    In addition, each foreign establishment is required under our 
existing regulations at Sec.  807.40(b) to designate a single U.S. 
agent. This proposal retains that requirement. The U.S. agent's 
responsibilities include:
     Helping FDA communicate with the foreign establishment;
     Responding to questions concerning the foreign 
establishment's devices; and
     Helping us schedule inspections.
    We would not object if the same individual serves as both the U.S. 
agent and the official correspondent for a foreign establishment, or if 
the same individual serves as the U.S. agent for more than one foreign 
establishment.
    We are not proposing to change the requirement that each foreign 
establishment be limited to designating only one U.S. agent. We 
interpret section 510(i) of the FD&C Act as allowing only one U.S. 
agent for each foreign establishment because section 510(i) refers to 
the U.S. agent in singular, rather than plural, terms. We also 
interpret section 510(i) of the FD&C Act as requiring that the U.S. 
agent must be located in the United States. These provisions are also 
consistent with the use of ``U.S. agent'' in the agency's interim final 
rule entitled ``Registration of Food Facilities Under the Public Health 
Security and Bioterrorism Preparedness Act of 2002'' (68 FR 58894 at 
58915, October 10, 2003).
    Currently, the provisions concerning a U.S. agent are set forth in 
our regulations at Sec. Sec.  807.3(r) and 807.40(b). Current Sec.  
807.3(r) defines U.S. agent as a person residing or maintaining a place 
of business in the United States whom a foreign establishment 
designates as its agent. The definition further states that the term 
``United States agent'' excludes mailboxes, answering machines or 
services, or other places where an individual acting as the foreign 
establishment's agent is not physically present. Section 807.40(b) also 
indicates that the U.S. agent must reside or maintain a place of 
business in the United States, and adds that if FDA is unable to 
contact the foreign establishment directly or expeditiously, FDA may 
provide information to the U.S. agent and this action will be 
considered as equivalent to giving the same information to the foreign 
establishment itself.
    This proposal would retain the requirements from the existing 
regulations concerning the U.S. agent.
2. What Legal Status Is Conferred by Registration and Listing?
    This proposal would retain provisions in our existing regulations, 
at Sec. Sec.  807.35(c) and 807.39, addressing the legal status of 
registrants and their devices. These provisions indicate that 
registration of an establishment or listing of a device does not denote 
approval of the establishment, the device, or other devices of the 
establishment; nor does it mean that a product may be legally marketed. 
Any representation that creates an impression of official approval or 
that a device is approved or is legally marketable because of 
registration or listing would be misleading and would constitute 
misbranding under section 502 of the FD&C Act (21 U.S.C. 352).
3. Would the Proposal Require Electronic Submission of Labeling and 
Advertisements?
    Current Sec.  807.31(e) requires owners or operators to submit 
labeling and in certain cases advertisements or other information for 
their device when they are specifically requested to do so by FDA. 
Currently such information, if requested, would be provided to us in 
paper format. This proposal would give owners or operators from whom 
copies of labeling or advertisements are requested under Sec.  807.31 
(which we are proposing to redesignate as Sec.  807.26) the option of 
submitting the information to us either in paper format or 
electronically. In those instances where the owner or operator chooses 
to submit the requested information electronically, they would do so by 
email rather than using FURLs. We intend to indicate in public Docket 
No. 92S-0251 that we are prepared to accept this information in 
electronic format.
4. What Registration and Listing Information Would Be Made Available 
for Public Disclosure?
    Current Sec.  807.37 pertains to the public availability of 
registration and listing information. The proposal would revoke the 
introductory text of current Sec.  807.37(a), which includes a 
description of the types of forms available for inspection, the 
addresses at which such forms can be inspected, and the addresses to 
which requests for verification of registration numbers and requests 
for locations of registered establishments can be directed. We are 
proposing to revoke this introductory text because these forms are no 
longer being used under FURLS. Instead, we intend to continue the 
current practice of making registration and listing information that is 
available for public disclosure accessible from our Web site. We expect 
that the registration and listing information available on the Web 
under the new electronic system will not change from that which is 
currently available. This initiative is consistent with the GPEA and 
also helps to reduce the number of Freedom of Information Act (5 U.S.C. 
552) requests we receive for registration and listing information.
5. How Would Part 11 Apply to the Electronic Submission of Registration 
and Listing Information?
    Under part 807 as revised by this proposal, the submission of 
registration and listing information would be subject to the 
requirements of part 11 (21 CFR part 11), except for the requirements 
under Sec.  11.10(b), (c), and (e) and the corresponding requirements 
under Sec.  11.30.
    In the Federal Register of March 20, 1997 (62 FR 13430), we 
published regulations on electronic records and electronic signatures 
(part 11). Part 11 regulations, among other things, set forth the 
criteria under which records submitted to us may be submitted in 
electronic format in lieu of paper records. Section 11.2(b) provides 
for the submission of electronic records instead of paper records 
provided the requirements of Part 11 are met and the documents or parts 
of documents to be submitted have been identified by us in public 
Docket No. 92S-0251 as being the type of submission we are prepared to 
accept in electronic format.
    Part 11 permits the widest possible use of electronic technology, 
compatible with our responsibility to promote and protect the public 
health (62 FR 13430). Part 11 helps to ensure the authenticity, 
integrity, and, when appropriate, the confidentiality of electronic 
records. Part 11 also helps to safeguard against the possible 
repudiation of those records. The controls in subpart B of part 11 are 
intended to further this purpose.
    In the Federal Register of September 5, 2003 (68 FR 52779), we 
announced the availability of a guidance for industry entitled ``Part 
11, Electronic Records; Electronic Signatures--Scope and Application'' 
(the part 11 guidance). The part 11 guidance explains our current 
thinking regarding the requirements and application of part 11 and 
states that we intend to exercise enforcement discretion in the manner 
specified in the guidance with respect to the validation (Sec.  11.10 
(a)), audit trail (Sec.  11.10(e) and (k)(2)), record retention (Sec.  
11.10(c)), and copies of records (Sec.  11.10(b)) requirements of part 
11, and any corresponding requirements in Sec.  11.30. In addition, we 
announced that

[[Page 14524]]

we intend to exercise enforcement discretion and do not intend to take 
(or recommend) action to enforce any part 11 requirements with regard 
to systems that were operational before August 20, 1997, the effective 
date of part 11 (commonly known as legacy systems) under the 
circumstances described in section III.C.3 of the part 11 guidance. The 
part 11 requirements from which we propose exemptions in this proposal 
differ from the part 11 requirements for which we intend to exercise 
enforcement discretion, as described in the part 11 guidance. They 
differ because the proposed exemptions in this rule are specific to the 
electronic submission of registration and listing information for 
devices that would be covered under proposed part 807, whereas the part 
11 guidance applies to the maintenance of all electronic records and to 
all electronic submissions subject to part 11.
    With respect to the electronic submission of registration and 
listing information, as previously noted, we believe, as provided in 
proposed Sec.  807.25(a), that several of the requirements in subpart B 
of part 11 are not necessary to further the goals of part 11. Because 
we control the electronic device registration and listing system 
(FURLS), certain controls for systems would not apply to the submission 
of registration and listing information, such as:
     The ability to generate accurate and complete copies of 
records in both human readable and electronic form suitable for 
inspection, review, and copying by the agency (Sec.  11.10(b));
     The protection of records to enable their accurate and 
ready retrieval throughout the records retention period (Sec.  
11.10(c));
     The use of secure, computer-generated, time-stamped audit 
trails to independently record the date and time of operator entries 
and actions that create, modify, or delete electronic records (Sec.  
11.10(e)); and
     The corresponding controls of Sec.  11.30.
    You would be exempt from these subpart B controls because FURLS is 
designed to ensure the authenticity, integrity, and confidentiality of 
this information in several ways. For example, we would control the 
database, and you would only be able to enter and/or revise information 
in your own account. In addition, the database would contain records of 
registration and listing information, including the history of all 
changes to those records, and we could generate accurate and complete 
copies of these records.
    With respect to the electronic submission of labeling or 
advertisements in connection with device listing, we believe, as 
provided in proposed Sec.  807.26, that the following requirements in 
subpart B of part 11 are not necessary to further the goals of part 11:
     The validation of systems to ensure accuracy, reliability, 
consistent intended performance, and the ability to discern invalid or 
altered records (Sec.  11.10(a));
     The protection of records to enable their accurate and 
ready retrieval throughout the records retention period (Sec.  
11.10(c));
     Limiting system access to authorized individuals (Sec.  
11.10(d));
     The use of secure, computer-generated, time-stamped audit 
trails to independently record the date and time of operator entries 
and actions that create, modify, or delete electronic records (Sec.  
11.10(e));
     The use of operational system checks to enforce permitted 
sequencing of steps and events, as appropriate (Sec.  11.10(f));
     The use of authority checks to ensure that only authorized 
individuals can use the system, electronically sign a record, access 
the operation or computer system input or output device, alter a 
record, or perform the operation at hand (Sec.  11.10(g));
     The use of device checks to determine, as appropriate, the 
validity of the source of data input or operational instruction (Sec.  
11.10(h));
     The use of appropriate controls over certain systems 
documentation (Sec.  11.10(k)); and
     The corresponding controls of Sec.  11.30.
    We are proposing to exempt the electronic submission of labeling 
and advertisements from these controls for systems because we believe 
these requirements are not critical to ensure the quality of the 
labeling and advertisements that would be submitted under this proposed 
rule and we do not think it is necessary for industry to expend 
resources on controls that are not necessary to further the goals of 
part 11.
    With regard to labeling and advertising submissions in electronic 
format, we recognize there are some differences with respect to the 
exemptions from part 11 requirements provided in this proposed rule 
(that is, Sec.  11.10(a), (c) through (h), and (k), and the 
corresponding requirements of Sec.  11.30), and the part 11 
requirements set forth in the part 11 guidance for which we intend to 
exercise enforcement discretion (that is, Sec.  11.10(a) through (c), 
(e), and (k)(2), and the corresponding requirements in Sec.  11.30). 
Although this proposal does not provide an exemption from Sec.  
11.10(b) for the labeling and advertisements, the part 11 guidance 
announces that we intend to exercise enforcement discretion with 
respect to that section in the manner described in the guidance.
    If this proposed rule is finalized, we intend to identify in public 
Docket No. 92S-0251 the registration and listing information and the 
labeling and advertising information specified previously as types of 
records that we are prepared to accept in electronic format.

F. Conforming Actions

    The proposed changes will not result in changes to any regulations 
other than part 807.

V. Legal Authority

    We have the legal authority to amend our regulations on foreign and 
domestic establishment registration and listing for human devices. The 
statutory basis for our authority includes sections 201, 301, 501, 502, 
510, 513, 515, 519-520, 701, 704, 801, and 903 of the FD&C Act (21 
U.S.C. 321, 331, 351, 352, 360c, 360e, 360i-360j, 371, 374, 381, and 
393); and sections 361 and 368 of the Public Health Service Act (42 
U.S.C. 264 and 271) (the PHS Act).
    Section 510(c) of the FD&C Act requires every person upon first 
engaging in the manufacture, preparation, propagation, compounding, or 
processing of a device to immediately register with the Secretary his 
name, place of business, and the establishment. The provisions in 
section 510(b) and (d) of the FD&C Act require annual registration and 
registration of additional establishments, respectively. As amended by 
section 222 of FDAAA, section 510(b) of the FD&C Act requires that 
annual registration take place during the period beginning on October 1 
and ending on December 31 of each year. Section 510(i) of the FD&C Act, 
as amended by section 222 of FDAAA, requires any establishment within 
any foreign country engaged in the manufacture, preparation, 
propagation, compounding, or processing of a device that is imported or 
offered for import into the United States, upon first engaging in such 
activity, to immediately register with the Secretary through electronic 
means, and thereafter to register annually during the period beginning 
on October 1 and ending on December 31 of each year. These provisions, 
together with section 701(a) (among others) of the FD&C Act,

[[Page 14525]]

authorize us to require the submission of the registration information 
specified in the proposal. The information specified in this proposal 
would help us identify who is manufacturing, repacking, or relabeling 
devices and where those operations are being performed. In addition, 
some information (e.g., official correspondent information) would help 
us communicate with establishments more effectively and schedule 
inspections more efficiently.
    Section 510(j)(1) of the act requires every person who registers to 
file with the Secretary, at the time of registration, a list of all 
devices that are being manufactured, prepared, propagated, compounded, 
or processed by the registrant for commercial distribution. That list 
must be prepared in the form and manner prescribed by the Secretary and 
must be accompanied by a copy of labeling (or the label and package 
insert) and, in some cases, advertising, when requested. Section 
510(j)(2) of the FD&C Act, as amended by section 223 of FDAAA, requires 
each person who registers with the Secretary under this section to 
report listing information updates once each year during the period 
beginning on October 1 and ending on December 31 of each year. Listing 
information gives us a current inventory of marketed devices. These 
provisions and others of the FD&C Act, together with section 701(a) of 
the FD&C Act, provide authority for requiring the submission of the 
listing information set forth in this proposal. The device listing 
information specified in this proposal would help us: (1) Develop a 
more current, robust inventory of devices as a counter-terrorism 
measure; (2) administer our postmarket surveillance programs more 
effectively; (3) facilitate recalls of products; (4) identify devices 
in short supply in the event of a national emergency; and (5) identify 
devices marketed in violation of the FD&C Act.
    Section 510(p) of the FD&C Act, as amended by section 224 of FDAAA, 
requires that registration and listing information be submitted 
electronically, subject to FDA's grant of waivers to individual 
requestors who meet the criteria set forth in section 510(p). 
Electronic receipt of registration and listing information will enable 
us to shift resources from performing more ministerial tasks, such as 
data entry, to pursuing important public health objectives such as 
those described in section I of this document. Electronic receipt of 
registration and listing information also will help us with the 
efficient enforcement of the act because we would be able to 
distinguish situations where there has been noncompliance with 
registration and listing requirements from situations where there have 
been no changes in information. The failure to register or list is a 
prohibited act under section 301(p) of the FD&C Act and the failure to 
do either renders a device misbranded under section 502(o) of the FD&C 
Act.

VI. Analysis of Economic Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The Office of Management 
and Budget has determined that this proposed rule is a significant 
regulatory action as defined by the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the burdens imposed by this proposed rule 
are expected to be minor, the agency proposes to certify that the final 
rule will not have a significant economic impact on a substantial 
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $130 million, using the most current (2007) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    We contracted with the Eastern Research Group, Inc. (ERG), to 
collect data, interview industry experts, and estimate the costs and 
benefits of the proposed rule. The analysis in support of the effects 
of the proposed rule (ERG Memo) is on file with the Division of Dockets 
Management. ERG identified several very small impacts, both costs and 
benefits, associated with this proposed rule. For most of these 
impacts, ERG found the incremental costs and savings to be so small 
that it was not a meaningful exercise to generate numeric estimates.\1\ 
ERG was able identify recurring costs associated with this proposed 
rule, plus additional costs that would not apply to U.S. 
establishments. After updating ERG's findings with more recent cost 
information, we find annual costs of $340,000 associated with this 
proposed rule, and an additional $138,000 that would only affect non-
U.S. establishments. We were unable to quantify specific benefits 
attributable to the proposed rule. However, we believe the ultimate use 
of electronic registration and listing data, the mandate under the 
Bioterrorism Act to collect additional pieces of registration data, and 
the requirement under the Bioterrorism Act and FDAAA that information 
be submitted to FDA electronically justify taking this action.
---------------------------------------------------------------------------

    \1\ ERG memorandum from Cal Franz, et al., September 15, 2008, 
(hereinafter referred to as ERG Memo), p. 1.
---------------------------------------------------------------------------

A. The Need for Regulation

    As discussed elsewhere in this preamble, section 224 of FDAAA 
amended section 510(p) of the FD&C Act to require establishment 
registrations and device listings to be submitted to FDA by electronic 
means unless the Secretary grants a waiver from electronic submission 
requirements. We currently maintain databases that contain 
establishment registration and device listing information obtained from 
owners and operators of device establishments. Prior to FDAAA, these 
databases relied on paper forms submitted by the owners and operators 
to us, which were then forwarded by us to a data entry contractor for 
input into our device registration and listing databases.
    Our device registration and listing databases play an important 
role in our efforts to accomplish many regulatory and statutory 
objectives. For example, we can use this information to identify device 
manufacturers to facilitate recalls or information alerts in the case 
of potential safety concerns. We also use it to plan and conduct 
inspections, administer postmarket surveillance, generate estimates of 
the number of businesses that are affected by our rulemaking, and to 
otherwise exercise competent oversight of the device industry.
    The quality and completeness of these databases depends on prompt 
submission of information and the

[[Page 14526]]

immediate inclusion of the data in our system. Under a paper-based 
registration and listing system, we were unable to readily verify the 
accuracy of the information submitted and, in some instances, 
manufacturers were not timely in informing us of changes. In addition, 
because we were using physical paper forms, it was possible for 
information to be mishandled or lost before being added to the system, 
thereby further reducing the reliability of the databases.
    In accordance with FDAAA, the agency began collecting registration 
and listing information using FURLS, FDA's new Internet-based 
electronic registration and listing system which became operational on 
October 1, 2007. The electronic submission of information makes the 
registration and listing process more efficient for industry and allows 
us to review and use such information more quickly, thus helping to 
ensure that medical devices will be safe and effective.
    Despite the obvious public health advantages to society of using an 
electronic device registration and listing system, the private returns 
alone would not be adequate to move the entire device industry to a new 
registration and listing format that would meet the requirements of 
section 510(i) and (p) of the FD&C Act. Because the social benefits are 
largely external to the firms, the large number of entities operating 
individually cannot be expected to voluntarily move to a new uniform 
standard. Few entities would choose to adopt a new format without 
significant private benefits.

B. Background

    ERG examined FDA's databases of registered device establishments 
and listed devices and estimates that revisions to the existing device 
registration and listing regulations would affect approximately 29,370 
owner-operators of approximately 33,500 registered device 
establishments, and 89,200 listed devices. Of the roughly 33,500 
registered establishments, approximately 19,700 are registered as 
domestic and 13,800 are registered as foreign.\2\
---------------------------------------------------------------------------

    \2\ See ERG , appendix B, table 1.
---------------------------------------------------------------------------

    Under the existing regulations, with certain exceptions, owners or 
operators of establishments that engage in the manufacture, 
preparation, propagation, compounding, assembly, or processing of a 
device intended for human use must, in addition to other requirements, 
register their establishments and submit listing information for each 
of their devices in commercial distribution. Foreign device 
establishments engaged in the manufacture, preparation, propagation, 
compounding, or processing of a device that is imported or offered for 
import into the United States must comply with the registration and 
listing requirements, including the requirement to identify a U.S. 
agent. Until the recent change to electronic submissions mandated by 
section 224 of FDAAA, all domestic and foreign registration and listing 
information was submitted using paper forms.

C. The Proposed Regulation

    A major objective of this proposal is to update FDA's regulations 
at part 807 to reflect the requirement for electronic submission of 
establishment registration and device listing information as required 
by FDAAA. A paper-based system of registering and listing is 
burdensome. It does not facilitate timely updates, which does not allow 
for the best use of these data in inspections and recalls. We believe 
that electronic submission of registration and listing information 
improves the quality and timeliness of information available to FDA. In 
addition, a system of electronic registration and listing improves the 
quality and timeliness of information available to health care 
professionals and consumers. Furthermore, to the extent that these 
quality improvements to the registration and listing process facilitate 
device recalls, complement postmarketing surveillance programs, help 
ensure the safety of imported devices, improve the scheduling and 
planning of inspections, and otherwise assist the agency in carrying 
out its statutory and regulatory objectives, there is a broad public 
health benefit. Moreover, the development and maintenance of high 
quality databases of information about devices and device 
establishments would enhance future uses of technology in the delivery 
of health care. An electronic database that contains current and 
accurate information about devices could, for example, facilitate the 
development of technology that would allow for communication among 
devices, giving them additional functionality and the potential for 
interoperability.
    This proposed regulation would also slightly modify the types of 
information that would need to be submitted as registration and listing 
information. However, these modifications would be minor and are 
generally consistent with achieving a more accurate and useful database 
of device industry information.

D. Estimated Impacts

    ERG reviewed the proposed registration and listing regulation, 
comparing it to the current provisions, and projected the impacts of 
the proposed regulation. A memorandum prepared by ERG based on this 
review identifies eight areas where revisions to the current device 
registration and listing provisions may affect the cost of 
compliance.\3\ These impacts would stem from provisions associated 
with:
---------------------------------------------------------------------------

    \3\ ERG memo, p. 3.
---------------------------------------------------------------------------

     The creation of an account on FURLS;
     The requirement for submission of additional information 
as part of the annual registration process;
     Modifications to requirements relating to registration 
information updates;
     The requirement for submission of additional information 
when listing a device;
     Changes relating to the requirement for semiannual review 
and update of device listing information;
     The waiver from the requirement to register and list by 
electronic means;
     The proposed elimination of the exemptions from 
registration and listing requirements for foreign establishments whose 
devices enter a foreign trade zone and are re-exported from the foreign 
trade zone without having entered U.S. commerce and the exemption for 
devices that are imported under section 801(d)(3) of the FD&C Act 
(import-for-export provision); and
     The proposed elimination of the exemption from 
registration and listing requirements for contract manufacturers and 
contract sterilizers who do not commercially distribute the devices.
    Because most of the identified regulatory impacts only slightly 
increase or decrease the costs of registering and listing, sometimes 
involving offsetting impacts, we present the impacts grouped by the 
eight impact areas identified previously, as opposed to trying to 
present the impacts as distinct groups of costs and benefits.
1. Creation of FURLS Accounts
    Under the proposed rule, establishments would go through the one-
time process of creating a FURLS account. According to ERG, the costs 
associated with setting up the FURLS account are negligible.\4\
---------------------------------------------------------------------------

    \4\ ERG memo, p. 5
---------------------------------------------------------------------------

2. Changes to Annual Registration Information
    This proposed rule could affect the burden on establishments by 
changing the information they submit in the annual registration 
process. ERG found that differences in the information collected 
currently and under the

[[Page 14527]]

proposed rule would be minor and should not increase the time spent 
completing the registration.\5\ Some of the additional information is 
already submitted voluntarily. For example, the e-mail addresses for 
the establishment's official correspondent and owner-operator, as well 
as the universal resource locator (URL) for the establishment's Web 
site, are already being collected. There would be little, if any 
additional burden for those establishments not currently providing this 
information. There would be modest savings associated with the annual 
registration process, as establishments would be able to access and 
edit registration information online and would no longer have to wait 
for physical forms to be mailed from FDA, review them, make edits, and 
mail the forms back to FDA.
---------------------------------------------------------------------------

    \5\ ERG memo, p. 6.
---------------------------------------------------------------------------

    As amended by section 321 of the Bioterrorism Act, section 510(i) 
of the FD&C Act requires foreign establishments whose devices are 
imported or offered for import to the United States to identify and 
provide contact information for importers of the establishment's device 
that are known to the establishment and also those persons who import 
or offer for import the device into the United States. According to the 
ERG memo, foreign establishments identifying importers known to them 
and persons who import or offer for import the establishments' devices 
would typically be identifying one or two entities of each type with 
readily available contact information, so the impact would be 
negligible.\6\ OMB Circular A-4 directs us to carefully evaluate new 
U.S. rules that might act as non-tariff barriers to imported goods. As 
the burden to these foreign establishments would be quite small and 
would not have a significant adverse effect on trade, the impact on 
U.S. consumers from this provision would be negligible.
---------------------------------------------------------------------------

    \6\ ERG memo, p. 5.
---------------------------------------------------------------------------

3. Changes Relating to the Requirement to Update Registration 
Information
    Under proposed Sec.  807.22(b)(2), establishments would be required 
to update their registration within 30 days if their registration 
information were to change. Current Sec.  807.26 requires that 
establishments update registration information for a change in 
ownership or a change in the location of the establishment. As the 
proposed rule includes a broader set of circumstances requiring a 
mandatory update, it has the potential to be slightly more burdensome. 
Under the proposed rule, however, establishments would provide updates 
electronically, as opposed to submitting such information to FDA using 
a paper form as required by current Sec.  807.26. ERG found that the 
ability to submit updated information through FURLS rather than 
completing and mailing paper forms would result in a net reduction in 
administrative burden and, therefore, a cost savings to establishments. 
ERG did not quantify the amount of the estimated savings, but we feel 
it would roughly negate any increase in burden from the increased 
likelihood of a mandatory update.
4. Requirement for Additional Device Listing Information
    Under proposed Sec.  807.25, establishments would be required to 
submit additional information, including 510(k) numbers and HDE numbers 
among the types of premarket submission numbers submitted to FDA for 
non-exempt devices. Establishments would also submit all proprietary 
and brand names under which each device is marketed. Although the 
agency already collects proprietary or brand names as part of device 
listings, the device listing form specified for use under the existing 
regulation has a single block of 80 characters for proprietary and 
brand names, which may have been restricting the amount of information 
establishments have been providing. In contrast, establishments using 
FURLS to list their devices have an unlimited amount of space within 
which to provide information and therefore could submit more data. 
According to the ERG memo, device listings would rarely have more than 
three proprietary or brand names, so the additional information that 
establishments would be providing under the proposed rule would be 
limited.\7\
---------------------------------------------------------------------------

    \7\ ERG memo, p. 5.
---------------------------------------------------------------------------

    Under proposed Sec.  807.25(g)(4), establishments also would be 
required to submit 510(k) and HDE numbers for non-exempt devices as 
part of the listing process. This information has been collected by FDA 
on a voluntary basis since 2005. It is our experience from processing 
these forms that most establishments submitting device listings since 
this practice began in 2005 already provide 510(k) and HDE numbers. 
Because these establishments already are complying with the proposal, 
they would not face an additional burden as a result of this new 
requirement. However, there was an additional burden associated with 
providing 510(k) and HDE numbers for those devices listed prior to 
2005. Because we have already begun to collect information on these 
devices electronically, much of this one-time burden has already been 
incurred. Based on a query of non-exempt listings included in FDA's 
registration and listing database, FDA estimated that 9,300 owners or 
operators would provide submission numbers for approximately 31,000 
device listings. We believe that affected owners or operators needed 
only a few minutes to look up this information from readily available 
sources.\8\ ERG did not attempt to quantify this very small burden, but 
noted that the inclusion of the 510(k) number in the device listing 
would result in significant benefits. Such information would improve 
our postmarket surveillance efforts by permitting devices to be tracked 
based on the submission number assigned to the particular device, as 
opposed to the previous method of tracking based on the reported 
product codes which did not necessarily correspond to the product codes 
under which a device was cleared. Also, having the registrant supply 
the premarket submission number and FDA determine the appropriate 
product code saves time, as incorrect product codes can lead to delays 
in listing.
---------------------------------------------------------------------------

    \8\ ERG memo, p. 6.
---------------------------------------------------------------------------

5. Changes Relating to Review and Update of Device Listings
    Section 510(j)(2) of the FD&C Act, as amended by section 223 of 
FDAAA, now requires device listings to be updated once each year during 
the period beginning on October 1 and ending on December 31. 
Previously, as reflected in the current registration and listing 
regulations, registrants had to review and update their device listings 
on a semiannual basis, during June and December. In the past, FDA has 
not strictly enforced this requirement but has encouraged 
establishments to update their listings throughout the year whenever 
information has changed. Thus, although the required updates would be 
less frequent and less burdensome, we recognize the potential for a 
minor impact associated with increased enforcement of an existing 
requirement. We believe any additional impact would be extremely small, 
and we do not attempt to quantify it.
6. Requests for a Waiver from Submitting Information Electronically
    Under the proposed rule, parties for whom registering and listing 
by electronic means is not reasonable may request a waiver from FDA. 
Because one would only need to have access to a

[[Page 14528]]

computer, Internet access, and an e-mail address to register and list 
by electronic means, we do not anticipate that we will receive many 
requests for waivers.
    For the first few months of operation (i.e., October through 
December 2007) of the Web-based system, , FDA received fewer than 10 
requests for waivers from the requirement to submit registration and 
listing information electronically. As FDA received electronic 
submissions for more than 16,000 establishments over that period, these 
requests amount to about 0.06 percent of the total number of 
establishments that responded.
    Based on information taken from our databases as of October 2007, 
FDA estimated there were 29,370 owners or operators who collectively 
registered a total of 33,490 device establishments. If 0.06 percent of 
the 33,490 total device establishments would request waivers from FDA, 
there would be 20 requests (33,490 x 0.0006). We estimate that the 
annual burden on these establishments would be an hour of time from a 
mid-level manager to draft, approve, and mail a letter. Assuming a 
burden of 20 hours and a labor cost of $41 per hour including benefits, 
the cost for all affected establishments would be $820 ($41 per hour x 
20 hours).\9\ This estimate may overstate the actual burden, as we 
received only nine waiver requests in 2008.
---------------------------------------------------------------------------

    \9\ We use a mean wage rate of $31.55 for compliance officers in 
the medical equipment and supplies manufacturing industry and add 30 
percent for benefits.
---------------------------------------------------------------------------

    We anticipate a small number of additional firms would enter the 
device industry over the next several years and would need to list and 
register. To the extent that a small fraction of these firms would 
request waivers, there may be small additional costs in the future.
7. Elimination of Exemptions for Some Foreign Establishments
    Under current Sec.  807.40(a), foreign establishments are not 
required to comply with the registration and listing requirements if 
their device enters a foreign trade zone and is re-exported from that 
foreign trade zone without having entered U.S. commerce. As previously 
discussed, the proposed rule would eliminate the exemption from 
registration and listing requirements for such establishments.
    Current Sec.  807.40(c), which states that no device may be 
imported or offered for import into the United States unless the device 
is listed and is manufactured, prepared, propagated, compounded, or 
processed at a registered foreign establishment, also states that this 
restriction does not apply to a device imported under section 801(d)(3) 
of the FD&C Act (``import-for-export'' provision). As previously 
discussed, we are proposing to eliminate the exemption from 
registration and listing requirements for devices imported under 
section 801(d)(3). This means such devices would have to be listed and 
the foreign establishments that manufacture these devices would have to 
register with FDA. ERG estimates that the burden of listing would be 
2.5 hours per affected device. Assuming an hourly labor cost of $41 per 
hour, the cost of this provision to foreign establishments would be 
$103 per device.
    ERG has reviewed the databases maintained by FDA's Division of 
Import Operations and Policy and found that 1,344 shipments of devices 
entered the United States under the ``import-for-export'' provision in 
2006.\10\ This figure represents approximately 0.13 percent of the 
device shipments to the United States. If each of these shipments 
required establishment registration and device listing, the cost to 
foreign exporters would be less than $138,000 (1,344 shipments x 2.5 
hours per shipment x $41/hour). These are one-time costs, as subsequent 
shipments of the same device would not require an additional 
registration and listing. ERG concludes foreign establishments may 
incur future costs if there are shipments of devices not previously 
listed and assumes the estimated first year cost is incurred annually. 
We believe future annual costs would be substantially less than 
$138,000 but we do not attempt to quantify them.
---------------------------------------------------------------------------

    \10\ ERG memo, p. 10.
---------------------------------------------------------------------------

    ERG was unable to obtain information on the number of devices and 
firms affected by the loss of the exemption for devices imported into 
foreign trade zones. We believe the impact of this loss of exemption on 
individual foreign firms would be very small, but welcome comment on 
this issue.
    Domestic device establishments would not face a substantial burden 
as a result of the elimination of these exemptions. As these devices 
are not intended for U.S. commerce, there would be no impact on the 
domestic market for these devices. Moreover, based on the small cost 
per affected device, we believe the elimination of these exemptions 
would have a negligible impact on U.S. industries doing ``import-for-
export'' and operating in foreign trade zones.
    For this analysis, we assume that the foreign establishments that 
would be losing these exemptions are foreign entities and not merely a 
foreign presence of a domestic entity. We lack detailed information on 
these establishments and welcome comment on this issue.
8. Elimination of Registration and Listing Exemptions for Contract 
Manufacturers and Sterilizers Who Do Not Commercially Distribute the 
Devices
    Under current Sec.  807.20(a)(2), (c)(1), and (c)(2), contract 
manufacturers and contract sterilizers are exempt from registration and 
listing obligations if they make or sterilize a device according to 
another person's specifications for commercial distribution by the 
person who developed the specifications. This proposed rule would 
eliminate the exemption from registration and listing for contract 
manufacturers and contract sterilizers who do not commercially 
distribute. This means that those contract manufacturers and contract 
sterilizers that currently do not register or list would be required to 
do so. Moreover, because there are recurring obligations associated 
with registration and listing, these firms would bear an additional 
annual burden.
    According to our registration and listing database, as of October 
2007, there were 1,304 registered contract manufacturers who had not 
previously listed any products. Of these 1,304 establishments, 736 re-
registered in 2006. We also believe there may be contract manufacturers 
not registered that would be registering for the first time because of 
the loss of exemption. We do not know the number of contract 
manufacturers that would be required to register and list, but for the 
purposes of this analysis, we estimate that 736 establishments that 
would need to register and initially list products. We invite comment 
on this estimate.
    Based on the October 2007 estimates, the registration and listing 
database contains about 89,200 listed devices and approximately 33,500 
registered establishments, or about 2.66 devices per establishment. If 
that ratio were to hold for the estimated 736 affected contract 
manufacturers, we would expect 1,958 additional device listings under 
the proposed rule.
    Between 1999 and 2006, there was an average of 306 initial contract 
manufacturer registrations each year. We therefore estimate 306 
additional contract manufacturers would initially register in 2008 (for 
fiscal year 2009) and would also incur costs to list their devices, for 
a total of 1,042. At 2.66 devices per establishment, this would

[[Page 14529]]

result in 814 additional listings, for a total of 2,772.\11\
---------------------------------------------------------------------------

    \11\ We do not follow the assumption in the ERG memo that half 
of these contract manufacturers would not register and pay user 
fees.
---------------------------------------------------------------------------

    According to our registration information, fewer than 160 
establishments perform contract sterilizations only. Of these, 116 do 
not list devices. Our registration and listing database includes 533 
listings for 114 contract sterilizers, or about 4.68 devices per 
establishment. Under the proposed rule, the 116 contract sterilizers 
who currently register would also have to list. Assuming these contract 
sterilizers would list 4.68 devices per establishment, this would 
result in 543 additional listings.
    ERG estimates that the process of registration and listing would 
require 2.5 hours of time per listed device each year.\12\ At a labor 
rate of $41 per hour, including benefits, the cost would be $103 per 
device or about $270 per contract manufacturing establishment ($103 per 
listing x 2.66 listings) and $480 per contract sterilizing 
establishment ($103 per listing x 4.68 listings). Across all affected 
contract manufacturers, including those registering for fiscal year 
2009, the cost would be a recurring $284,000 ($41 per hour x 2.5 hours 
x 2,772 listings). For contract sterilizers, the cost would be $56,000 
($41 per hour x 2.5 hours x 543 listings). Thus, the impact on contract 
manufacturers and contract sterilizers would be an annual $340,000 
($284,000 + $56,000). We recognize that we may not be aware of some 
contract sterilizers that have never registered. We believe there are 
few if any such firms and do not account for them in our analysis, but 
invite comment on this issue.
---------------------------------------------------------------------------

    \12\ ERG memo, p. 9.
---------------------------------------------------------------------------

    The loss of the exemption for contract manufacturers and 
sterilizers who do not commercially distribute the devices will not 
only result in social economic costs, but will also result in transfers 
associated with the payment of user fees. Contract manufacturers and 
sterilizers that are required to register will also be required to pay 
user fees. According to section 212 of FDAAA, the Fiscal Year (FY) 2009 
establishment registration fee is $1,851. At that rate, we estimate FY 
2009 fees of $2.14 million, $1.93 million paid by the 1,042 contract 
manufacturers and $215,000 paid by the 116 contract sterilizers.
    Table 1 of this document summarizes the projected quantified 
impacts of this proposed rule. The total annual costs are $340,000. 
Foreign establishments would face an additional annual burden of 
$138,000 due to the loss of the exemptions from registration and 
listing requirements relating to devices entering a foreign trade zone 
that are later re-exported without having entered U.S. commerce and 
devices that are imported into the United States under section 
801(d)(3) of the FD&C Act. There would also be a transfer of $2.14 
million in additional user fees paid by contract manufacturers and 
sterilizers.

                                Table 1.--Projected Impacts of the Proposed Rule
----------------------------------------------------------------------------------------------------------------
                               No. of Affected
 Establishment Category    Establishments/Devices     Incremental Time    Cost per Hour\1\  Total Annual Cost\3\
----------------------------------------------------------------------------------------------------------------
Requests for a Waiver     20 establishments         1 hr                               $41                  $820
 from Submitting
 Information
 Electronically
----------------------------------------------------------------------------------------------------------------
Foreign establishments    none\2\                   2.5 hrs                            $41                 $0\2\
 shipping to United
 States under import-for-
 export and to foreign
 trade zones
----------------------------------------------------------------------------------------------------------------
Elimination of            2,772 devices, 1,042      2.5 hrs                            $41              $284,000
 Exemptions for Contract   establishments
 Manufacturers
----------------------------------------------------------------------------------------------------------------
Elimination of            543 devices, 116          2.5 hrs                            $41               $56,000
 Exemptions for Contract   establishments
 Sterilizers
----------------------------------------------------------------------------------------------------------------
All other                 negligible                --                                  --         negligible\3\
----------------------------------------------------------------------------------------------------------------
Total                     1,178 establishments      --                                  --              $340,000
                           3,315 devices
----------------------------------------------------------------------------------------------------------------
\1\ Average hourly wage for medical equipment and supplies compliance officer, adjusted for benefits.
\2\ Provision would not be expected to affect U.S. establishments. An estimated 1,344 foreign establishments
  would face additional annual costs of $138,000.
\3\ Estimated incremental time costs are offset by incremental time savings.

     Table 2.--Economic Transfers Associated with the Proposed Rule
------------------------------------------------------------------------
     From        To    Description   Cost per Entity       Total Cost
------------------------------------------------------------------------
1,042          U.S.    Establishme             $1,851      $2.14 million
 Contract       Gover   nt
 Manufacturer   nment   Registrati
 s and 116              on Fees
 Contract
 Sterilizers
------------------------------------------------------------------------

    The proposed rule would result in benefits associated with an 
electronic registration and listing database that would provide more 
up-to-date and complete information. The electronic registration and 
listing database system could also support future medical and health 
information technology initiatives. The proposed rule would increase 
the efficiency of the registration and listing process by eliminating 
all or nearly all paper submissions. With registration and listing in 
an electronic format, we are able to review the submitted information 
more quickly and can contact submitting firms immediately through email 
if any additional information is needed. In addition, having a database 
of registered establishments and listed devices that is more accurate 
and complete can

[[Page 14530]]

increase patient safety. For example, an electronic database that 
includes 510(k) clearance numbers and current product codes for devices 
would help facilitate timely notification of recalls of certain unsafe 
devices and prompt identification of the affected manufacturers.
    Although the scope of the proposed rule does not extend beyond 
registration and listing, the resulting high-quality, electronic 
database would facilitate future uses of technology for the public 
benefit. A current electronic database of device information could, for 
example, facilitate the development of future devices utilizing 
wireless connectivity and the interoperation of such devices with 
hospital information systems, or with handheld personal digital 
assistant (PDA)-type clients used by health care providers or those 
managing hospital inventories.
    Additionally, having a paper-based registration and listing system 
is inconsistent with section 510(p) of the FD&C Act, as amended by 
section 224 of FDAAA, and might deter the medical device industry and 
healthcare providers from investing in new initiatives that would make 
use of electronic device listing and establishment registration data.

E. Regulatory Flexibility Act

    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The impact of this proposed rule is almost entirely 
attributable to the requirement that contract manufacturers and 
contract sterilizers register and list. We have estimated the impacts 
on small entities and find that the costs associated with registering 
and listing would not be a significant burden for even the smallest of 
contract manufacturers and contract sterilizers. Moreover, failing to 
remove this exemption for contract manufacturers and sterilizers would 
reduce the benefits potentially realized from this proposed rule. These 
benefits would include improving the quality and timeliness of 
information, facilitating device recalls, complementing postmarket 
surveillance programs, ensuring the safety of imported devices, and 
improving the scheduling and planning of inspections. Requiring that 
contract manufacturers and sterilizers register and list allows for the 
appropriate oversight of these types of facilities. For other elements 
of this proposed rule, the costs per entity are very small and we do 
not believe that this proposed rule would have a significant economic 
impact on a substantial number of small entities.
    As described earlier in this preamble, this proposed rule would 
revise the agency's regulations at part 807 to make them consistent 
with the requirement under FDAAA that the agency shift to an electronic 
registration and listing format. The incremental costs to 
establishments making this switch to electronic registration and 
listing are so small as to be difficult to quantify. Certain elements 
of the proposed rule may be burdensome to some entities, but these 
incremental burdens are estimated to be extremely small. The cost of 
submitting a waiver claiming electronic listing and registration to be 
unreasonable would be an estimated $41. The cost of registering and 
listing a device because of the loss of the exemptions from 
registration and listing requirements for devices imported into foreign 
trade zones or imported under section 801(d)(3) of the FD&C Act is not 
expected to have an effect on domestic establishments. Other elements 
of the proposed rule involve the submission of information not 
currently required but readily available and the estimated cost of 
compliance would be so small as to be difficult to estimate.
    Contract manufacturers and contract sterilizers who do not 
commercially distribute the devices they make or sterilize would be 
faced with a new requirement to register and list. We do not know how 
many of the affected contract manufacturers and contract sterilizers 
would be categorized as small. As shown in table 1 of this document, we 
estimate 1,042 affected contract manufacturers and 116 affected 
contract sterilizers. Our internal databases include some contract 
manufacturers and sterilizers that have in the past voluntarily 
registered. A review of the contract sterilizers in this database 
indicate that many are described in external databases as being part of 
NAICS code 339113 (Surgical Appliance and Supplies Manufacturing). 
Because of the specific expertise, capital requirements, and economies 
of scale associated with contract sterilization, we expect contract 
sterilizers would have more employees and more revenues per employee 
than would a typical establishment in this class. Medical device 
contract manufacturers fit in NAICS code 339112 (Surgical and Medical 
Instrument Manufacturing). For both of these industry classifications, 
the U.S. Small Business Administration has defined a small business as 
one with 500 or fewer employees.\13\
---------------------------------------------------------------------------

    \13\ U. S. Small Business Administration, ``Table of Small 
Business Size Standards Matched to North American Industry 
Classification System Codes,'' August 22, 2008, http://www.sba.gov/
idc/groups/public/documents/sba_homepage/serv_sstd_tablepdf.pdf.
---------------------------------------------------------------------------

    According to the U.S. Census, there are 1,352 establishments in 
class 339112 with 1,302 of them (96 percent) having fewer than 500 
employees.\14\ Census information on class 339113 lists 1,845 
establishments, with 1,805 of them (98 percent) having fewer than 500 
employees.\15\ Applying these profiles to our estimated contract 
manufacturers and contract sterilizers, there would be 1,000 small 
affected contract manufacturers (96 percent of 1,042) and 114 small 
affected contract sterilizers (98 percent of 118).
---------------------------------------------------------------------------

    \14\ U.S. Census Bureau, 2002 Economic Census, ``Surgical and 
Medical Instrument Manufacturing: 2002,'' Table 4, p. 4, released 
December 2004, http://www.census.gov/prod/ec02/ec0231i339112.pdf.
    \15\ U.S. Census Bureau, 2002 Economic Census, ``Surgical 
Appliance and Supplies Manufacturing,'' Table 4, p. 4, released 
December 2004, http://www.census.gov/prod/ec02/ec0231i339113.pdf.
---------------------------------------------------------------------------

    For class 339112 covering contract manufacturers, we consider the 
smallest establishment group with one to four employees. There are 388 
establishments with a total of 839 employees and a total value of 
shipments of approximately $130 million. Average revenue per employee 
is approximately $150,000. The average establishment in this group has 
2.2 employees and receipts of $331,000. As discussed in section V.I.D 
of this document, establishment registration user fees are $1,851 for 
FY 2009. As shown in table 1 of this document, the estimated annual 
burden of listing a device is 2.5 hours at $41 per hour, or $103. A 
small contract manufacturer with a single listed device would face an 
annual burden of $1,851 plus $103, or $1,954, which is 0.59 percent of 
annual revenues.
    Assuming the smallest contract sterilizers have five to nine 
employees, that particular group in class 339113 has 320 establishments 
with a total of 2,165 employees and a total value of shipments of 
approximately $380 million. Revenue per employee is approximately 
$175,000. The average establishment has 6.8 employees and receipts of 
$1.2 million. Contract sterilizers would face an annual establishment 
fee of $1,851 plus a cost of $103 per listed device. A small contract 
sterilizer with two listed devices would face an annual burden of 
$1,851 plus $2,057, or 0.17 percent of annual revenues.

[[Page 14531]]

    A $41 burden associated with a waiver request would be about 0.01 
percent of revenues for a small entity with revenues in the hundreds of 
thousands of dollars. As discussed earlier in this section and in 
section V.I.D of this document, other impacts associated with this 
proposed rule are all extremely small. We therefore tentatively 
conclude that the proposed rule, if issued, would not have a 
significant impact on a substantial number of small entities. We also 
believe affected entities currently possess the skills required to 
comply with the provisions of this proposed rule. FDA requests comment 
on the issue of whether this proposed rule would have a significant 
impact on a substantial number of small entities.
    FDA considered regulatory alternatives such as not regulating and 
not requiring registration and listing by contract manufacturers and 
contract sterilizers who do not commercially distribute devices. As 
explained earlier in this preamble, the electronic submission of 
information is mandated under FDAAA. Section A discusses the need to 
regulate in greater detail. The benefits associated with agency 
oversight of contract manufacturers and contract sterilizers justify 
the estimated costs of requiring that they register and list.

VII. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A 
description of these provisions is given below with an estimate of the 
annual reporting and recordkeeping burden. Included in the estimate is 
the time for reviewing instructions, searching existing data sources, 
gathering and maintaining the data needed, and completing and reviewing 
each collection of information.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Implementation of Sections 222, 223, and 224 of the Food and Drug 
Amendments Act of 2007 (OMB Control No. 0910-0625)--Revision

    FDA is proposing to amend its regulations governing medical device 
establishment registration and device listing. The proposed revisions 
would modify FDA's current regulations at part 807 to reflect recent 
statutory amendments to the device registration and listing provisions 
of the FD&C Act. FDAAA, which was enacted on September 27, 2007, 
amended section 510 of the FD&C Act by requiring domestic and foreign 
device establishments to begin submitting their registration and device 
listing information to FDA by electronic means rather than on paper 
forms, and also specified the timeframes when establishments are 
required to submit such information. In accordance with FDAAA, the 
agency launched FDA's Unified Registration and Listing System (FURLS), 
an internet-based registration and listing system. FDAAA requires 
electronic submission of device registration and listing information 
unless FDA grants a waiver request.
    In addition, this proposal would facilitate FDA's collection of 
additional registration information from foreign establishments as 
required by the Public Health Security and Bioterrorism Preparedness 
and Response Act of 2002 (Bioterrorism Act). It also would update 
certain provisions in part 807 to improve the quality of registration 
and listing information available to FDA. FDA relies on having complete 
and accurate registration and listing information in order to 
accomplish a number of important public health objectives.

A. Statutory Compliance

    To comply with the statutory deadline under the provisions of FDAAA 
for medical device establishment registration and device listing by 
electronic means, including waiver provisions, FDA initially obtained a 
6-month OMB approval of the collection of information requirements 
under the emergency processing provisions of the Paperwork Reduction 
Act (the PRA), and subsequently obtained a 3-year approval of these 
requirements under the same assigned OMB Control No. 0910-0625. With 
OMB approval of the collection of information requirements, FDA took 
several actions: (1) Developed an electronic form ``Device Registration 
and Listing Module,'' Form FDA 3673 and (2) developed and implemented 
the guidance entitled ``Guidance for Industry and FDA Staff-
Implementation of Medical Device Establishments Registration and Device 
Listing Requirements Established by the Food and Drug Administration 
Amendments Act of 2007.'' This guidance among other things explained 
the recent changes in the device registration and listing program and 
the process (instructions) for using FURLS, an Internet-based 
registration and listing system.

B. Transition Process From Paper to Electronic Submission

    The information collection requirements for paper submissions were 
approved under the assigned OMB control number 0910-0387 with the 
associated Forms FDA 2891, 2891a, and 2892. Upon approval of electronic 
registration and listing information collection requirements under 
FDAAA, FDA: ( 1) Replaced the paper forms FDA 2891, 2891a, and 2892 
with the electronic data collection instrument, Form FDA 3673; (2) 
revised the collection of information 0910-0387 for paper submissions 
to include only nonregistration and listing paperwork requirement, 
thereby reducing the annual reporting burden requirements (the 
registration and listing requirements under FDAAA were updated as a 
revision to the collection 0910-0625); (3) following notice in a June 
17, 2007, letter to firms, shut down the manual data entry system on 
September 15, 2007, and began using the new electronic system on 
October 1, 2007; and (4) sent each firm a letter on October 1, 2007, 
providing account and password information for the new system.
    Description: In accordance with the collection of information 
entitled ``Establishment Registration and Device Listing for 
Manufacturers and Initial Importers of Devices,'' medical device 
establishment owners and operators will be required to electronically 
submit establishment registration and device listing information.
    Section 510(c) of the FD&C Act requires owners or operators of 
domestic establishments upon first engaging in the ``manufacture, 
preparation, propagation, compounding, or processing`` of a device or 
devices in those establishments to immediately register their name and 
place of business and such establishment. Section 510(a)(1) of the FD&C 
Act defines the term ``manufacture, preparation, propagation, 
compounding, or processing'' to include ``repackaging or otherwise 
changing the container, wrapper, or labeling of any * * *

[[Page 14532]]

device package in furtherance of the distribution of the * * * device 
from the original place of manufacture to the person who makes final 
delivery or sale to the ultimate consumer or user.''
    Section 510(a)(2) of the FD&C Act mandates that the term ``name'' 
include, among other things, the name of each partner of a partnership, 
and the name of each corporate officer and director of a corporation. 
An owner or operator of a registered establishment must also 
immediately register any additional establishment that he owns or 
operates in any State and in which he begins the ``manufacture, 
preparation, propagation, compounding, or processing'' of a device 
(section 510(d) of the FD&C Act). An owner or operator of any 
establishment that engages in these activities must also re-register 
its establishment once each year during the period beginning on October 
1 and ending on December 31 of each year (section 510(b) of the FD&C 
Act, as amended by FDAAA).
    Section 510(i) of the FD&C Act contains certain registration 
requirements pertaining to foreign establishments (e.g., submission of 
the name of each importer of the establishment's device in the United 
States that is known to the establishment, submission of the name of 
each person who imports or offers for import the establishment's device 
to the United States for purposes of importation). Section 510(g) of 
the FD&C Act provides for certain exemptions from the registration 
requirements. In addition, section 510(p) of the FD&CAct, as amended by 
FDAAA, requires the electronic submission of device registration and 
listing information unless the Secretary grants a request for a waiver 
because use of electronic means is not reasonable for the person 
requesting the waiver.
    Section 510(j)(1) of the FD&C Act requires that every person who 
registers must, at the time of registration, submit a list of all 
devices that are being manufactured, prepared, propagated, compounded, 
or processed by him or her for commercial distribution which have not 
been previously listed by him or her. This information must be 
submitted in the form and manner prescribed by the Secretary (section 
510(j)(1) of the FD&C Act). Prior to FDAAA, section 510(j)(2) of the 
FD&C Act required certain changes in listing information to be reported 
every June and December, including any material changes in information 
previously submitted under the listing provisions. This information 
must now be provided only once each year during the period beginning on 
October 1 and ending on December 31.
    Section 510(e) of the FD&C Act permits the Secretary to prescribe a 
uniform system for the identification of devices intended for human use 
and may require that persons who are required to list such devices 
under section 510(j) shall list such devices in accordance with such a 
system. The disclosure provision in section 510(f) of the FD&C Act 
requires the Secretary to make available for inspection any 
registration filed under section 510. Section 510(f) also provides that 
certain listing information must be exempt from disclosure unless the 
Secretary finds that such exemption would be inconsistent with 
protection of the public health.
    Complete and accurate registration and listing information is 
necessary to accomplish a number of statutory and regulatory 
objectives, such as: Identification of establishments producing 
marketed medical devices, identification of establishments producing a 
specific device when that device is in short supply or is needed for 
national emergency, facilitation of recalls for devices marketed by 
owners and operators of device establishments, identification and 
cataloguing of marketed devices, administering postmarketing 
surveillance programs for devices; identification of devices marketed 
in violation of the law; identification and control of devices imported 
into the country from foreign establishments; and scheduling and 
planning inspections of registered establishments under section 704 of 
the FD&C Act.
    The electronic collection of establishment registration and device 
listing information from medical device establishment owners and 
operators also furthers the purpose of several statutes, including: The 
FDAAA, the Bioterrorism Act, MDUFMA, and GPEA.
    Description of Respondents: Owners or operators of establishments 
that engage in the manufacturing, preparation, propagation, 
compounding, or processing of a device or devices must register their 
establishments and submit listing information for each of their devices 
in commercial distribution. Notwithstanding certain exceptions, foreign 
device establishments that manufacture, prepare, propagate, compound, 
or process a device that is imported or offered for import into the 
United States must also comply with the registration and listing 
requirements. The total annual estimated burden imposed by this 
collection of information is 103,536 hours annually.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 3.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Annual
               21 CFR Section                   FDA Form Number          No. of         Frequency per     Total Annual         Hours per         Total
                                                                       Respondents         Response         Responses          Response          Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.20(a)\3\                                                3,673                 800                1               800                0.75         600
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.21(a)\3\                                                3,673                 125                1               125                0.5           63
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.21(b)\2\                                  ...................                  20                1                20                1             20
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.21(b)\3\                                  ...................                   1                1                 1                1              1
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.22(a)\3\                                                3,673               2,566                1             2,566                0.5        1,283
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.22(b)(1)\3\                                             3,673              29,100                1            29,100                0.75      21,825
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.22(b)(2)\3\                                             3,673               3,000                1             3,000                0.5        1,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.22(b)(3)\3\                                             3,673              24,870                1            24,870                1         24,870
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.26(e)\3\                                  ...................                 100                1               100                1            100
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 14533]]

807.34(a)\2\                                  ...................                  20                1                20                1             20
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.34(a)\3\                                  ...................                   1                1                 1                1              1
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.40(b)(2)\3\                                             3,673                  50                1                50                0.5           25
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.40(b)(3)\3\                                             3,673               1,836                1             1,836                0.25         459
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.41(a)\3\                                                3,673              11,348                1            11,348                0.5        5,674
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.41(b)\3\                                                3,673              11,348                1            11,348                0.5        5,674
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total one time burden                                                                                                                                 40
---------------------------------------------------------------------------------------------------------------------------------------------
Total recurring burden                                                                                                                            62,075
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ One Time Burden
\3\ Recurring Burden

                                                   Table 4.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Annual Frequency        Total Annual         Hours per
                21 CFR Section                   No. of  Respondents      per Recordkeeper           Records            Record           Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.25(d)\2\                                                    33,490                     1                33,490             .25                 8,373
--------------------------------------------------------------------------------------------------------------------------------------------------------
807.26\2\                                                       16,524                     4                66,096             .5                 33,048
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                             41,421
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Recurring burden.

    The currently approved reporting and recordkeeping burden for 
electronic registration and listing under OMB No. 0910-0625 is 71,319. 
The estimated reporting and recordkeeping burden for electronic 
registration and listing under the proposed rule is 103,536 hours, an 
increase of 32,217 hours. This increase is due to an under estimate of 
the original burden estimate for 0910-0625 and the incremental increase 
of respondents no longer exempt from these requirements.
    Burden estimates are based on recent experience with the existing 
medical device registration and listing program and the economic 
analysis provided by ERG. The changes to the actual data collected are, 
with one exception, very minor. We are assuming that it will take 
approximately the same amount of time to enter the data online using 
FURLS as it does to use the portable document format (PDF)-enabled 
forms that had been used for initial establishment registration prior 
to FURLS becoming operational in October 2007. Any additional burden 
associated with creating and using the Web-based system accounts (as 
shown in table 3 of this document under Sec.  807.21(a)) should be 
offset by the elimination of the need to re-enter identifying 
information concerning the establishment or product every time 
registration or listing information is updated, which was the case when 
updating such information using the PDF-enabled forms.
    The recurring burden for the new data collection under Sec.  807.41 
(import-related information provided by foreign companies exporting to 
the United States) was estimated based on the ERG memo. This report 
stated that foreign establishments would typically be identifying one 
or two importers and one or two persons who import or offer for import 
with readily available contact information.
    The estimates for creation of new user accounts under Sec.  
807.21(a) are based on the current number of owners or operators, and 
experience in account creation using the existing FURLS for Food 
Facility Registration. The estimates for the recurring years assume a 
similar increase in the number of new owner or operator numbers as were 
created in FY 2006.
    The estimate for Sec.  807.25(d) in table 5 of this document 
(recordkeeping burden) reflects the requirement that owners or 
operators keep a list of officers, directors, and partners for each 
establishment. Owners or operators will need to provide this 
information only when requested by FDA. However, it is assumed that 
some effort will need to be expended to keep such lists current.
    The requirements shown in table 5 for proposed Sec.  807.26 
(renumbered from Sec.  807.31), have not changed based on this revision 
to the registration and listing regulations. They reflect other 
recordkeeping requirements for devices listed with FDA, and the 
requirement to provide these records when requested by FDA. They are 
based on experience FDA has had with the existing regulation.
    This proposed rule also refers to previously approved collections 
of information found in FDA regulations. These collections of 
information are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in Sec.  807.35(b) have been 
approved under OMB control number 0910-0052. This rule is not going to 
impact the burden in 0910-0052 that is already accounted for in that 
information collection.
    To further clarify and track how the burden and associated changes 
for this proposed rule have been accounted for during the transition 
process from paper to electronic in which the information is

[[Page 14534]]

currently submitted by electronic means through FURLS, FDA has 
developed tables 5 and 6 of this document as follows:

                                        Table 5.--Reporting Requirements
----------------------------------------------------------------------------------------------------------------
  21 CFR Section/   Section of the 2007 Amendments/  OMB Control No.             21 CFR Section/  NPRM
  OMB Control No.                       0910-0625                    -------------------------------------------
     0910-0387     --------------------------------------------------              Electronic Format
-------------------                 Electronic Format                -------------------------------------------
   Paper Format    --------------------------------------------------
-------------------
     Forms FDA                                                                       Form FDA 3673
  2891,2891a, and                     Form FDA 3673
       2892
----------------------------------------------------------------------------------------------------------------
807.22(a) and                                                    222                                   807.22(a)
 807.40
----------------------------------------------------------------------------------------------------------------
807.22(b)                                                        223                                807.22(b)(3)
----------------------------------------------------------------------------------------------------------------
807.22(a) and                                                    224                                807.22(b)(1)
 807.40
----------------------------------------------------------------------------------------------------------------
807.22(b)                                                        224                                   807.22(a)
----------------------------------------------------------------------------------------------------------------
Not reported                                                     224                                   807.21(b)
----------------------------------------------------------------------------------------------------------------
Not reported                                                     224                                   807.21(c)
----------------------------------------------------------------------------------------------------------------

                                      Table 6.--Recordkeeping Requirements
----------------------------------------------------------------------------------------------------------------
  21 CFR Section/    Section of the 2007 Amendments  OMB Control No.             21 CFR Section/  NPRM
  OMB Control No                        0910-0625                    -------------------------------------------
     0910-0387     --------------------------------------------------              Electronic Format
-------------------                 Electronic Format                -------------------------------------------
   Paper Format    --------------------------------------------------
-------------------
     Forms FDA                                                                       Form FDA 3673
  2891,2891a, and                     Form FDA 3673
       2892
----------------------------------------------------------------------------------------------------------------
Not reported                                                     222                                   807.25(d)
----------------------------------------------------------------------------------------------------------------
807.31                                                           223                                      807.26
----------------------------------------------------------------------------------------------------------------

    In compliance with the PRA, the agency has submitted the revised 
information collection provisions of this proposed rule to OMB for 
review. Interested persons are requested to send comments regarding the 
information collection to OMB (see DATES and ADDRESSES sections of this 
document).

VIII. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IX. Proposed Effective Date

    FDA proposes that any final rule based on this proposal become 
effective 90 days after its date of publication in the Federal 
Register.

X. Proposed Compliance Dates

    The proposed rule does not affect self-executing statutory 
responsibilities. Those FDAAA provisions establishing registration and 
listing requirements that are self-executing must be complied with in 
accordance with the statute and do not depend on this proposed rule 
becoming final.

XI. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed rule, if finalized, would not contain policies that would 
have substantial direct effects on the States, on the relationship 
between the National Government and the States, or on the distribution 
of power and responsibilities among the various levels of government. 
Accordingly, the agency tentatively concludes that the proposed rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

XII. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

XIII. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES), and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but we are not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.
    1. Bureau of Labor Statistics, May 2008, National Industry-
Specific Occupational Employment and Wage Estimates, NAICS 339100--
Medical Equipment and Supplies Manufacturing, Occupation (SOC code): 
(131041) http://www.bls.gov/oes/current/naics4_339100.htm.
    2. Eastern Research Group memorandum from Cal Franz, Derek 
Singer, and John Eyraud to FDA, September 15, 2008.
    3. Office of Management and Budget, Circular A-4, Regulatory 
Analysis, Washington, DC, 2003, http://www.whitehouse.gov/omb/
circulars/a004/a-4.pdf.

List of Subjects in 21 CFR Part 807

    Imports, Medical devices, Reporting and Recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner

[[Page 14535]]

of Food and Drugs, it is proposed that 21 CFR part 807 be amended as 
follows:

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR 
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

    1. The authority citation for 21 CFR part 807 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 
360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.
    2. Amend Sec.  807.3 by:
    a. Adding ``and'' at the end of paragraph (e)(3);
    b. Removing ``;and'' at the end of paragraph (e)(4) and adding a 
period in its place;
    c. Removing paragraph (e)(5);
    d. Revising paragraph (i);
    e. Redesignating paragraphs (k) through (s) as paragraphs (l) 
through (t), respectively; and
    f. Adding a new paragraph (k) and adding paragraphs (u) through 
(y).
    The revisions and additions read as follows:

Sec.  807.3  Definitions.

* * * * *
    (i) Restricted device means a device for which a requirement 
restricting sale, distribution, or use has been established by a 
regulation issued under section 520(e) of the act, by order as a 
condition of premarket approval under section 515(d)(1)(B)(ii) of the 
act, or by a performance standard issued in accordance with sections 
514(a)(2)(B)(v) and 514(b) of the act.
* * * * *
    (k) Product code means the code used by FDA to identify the generic 
category of a device.
* * * * *
    (u) Fiscal year means the FDA fiscal year, which runs from October 
1 through September 30.
    (v) FURLS means the Food and Drug Administration's Unified 
Registration and Listing System,
    (w) FDA premarket submission number means the number assigned by 
FDA to a premarket device submission, such as a Premarket Approval 
Application (PMA); Investigational Device Exemption (IDE); Humanitarian 
Device Exemption (HDE); Investigational New Drug Application (IND); New 
Drug Application (NDA); or Premarket Notification (510(k)).
    (x) Importer means, for purposes of this part, a company or 
individual in the United States that is an owner, consignee, or 
recipient, even if not the initial owner, consignee, or recipient, of 
the foreign establishment's device that is imported into the United 
States. An importer does not include the consumer or patient who 
ultimately purchases, receives, or uses the device, unless the foreign 
establishment ships the device directly to the consumer or patient.
    (y) Person who imports or offers for import means, for purposes of 
this part, an agent, broker, or other entity, other than a carrier, 
that the foreign establishment uses to facilitate the import of its 
device into the United States.
    3. Revise Sec.  807.20 to read as follows:

Sec.  807.20  Who must register and submit a device list?

    (a) An owner or operator of an establishment not exempt under 
section 510(g) of the act or subpart D of this part who is engaged in 
the manufacture, preparation, propagation, compounding, assembly, or 
processing of a device intended for human use shall register and submit 
listing information for those devices in commercial distribution, 
except that registration and listing information may be submitted by 
the parent, subsidiary, or affiliate company for all the domestic or 
foreign establishments under the control of one of these organizations 
when operations are conducted at more than one establishment and there 
exists joint ownership and control among all the establishments. The 
term ``device'' includes all in vitro diagnostic products and in vitro 
diagnostic biological products not subject to licensing under section 
351 of the Public Health Service Act. An owner or operator of an 
establishment located in any State as defined in section 201(a)(1) of 
the act shall register its name, places of business, and all 
establishments and list the devices whether or not the output of the 
establishments or any particular device so listed enters interstate 
commerce. The registration and listing requirements shall pertain to 
any person who:
    (1) Initiates or develops specifications for a device that is to be 
manufactured by a second party;
    (2) Manufactures a device, including an establishment that 
sterilizes or otherwise makes a device for or on behalf of a 
specifications developer or any other person;
    (3) Repackages or relabels a device;
    (4) Reprocesses a single use device that has previously been used 
on a patient;
    (5) Acts as an initial importer as defined in Sec.  807.3(g), 
except that initial importers are not required to provide device 
listings for any device for which they did not initiate or develop the 
specifications for the device or repackage or relabel the device. 
However, the initial importer shall submit, for each such device, the 
name and address of the manufacturer. Initial importers shall also be 
prepared to submit, when requested by FDA, the proprietary name, if 
any, and the common or usual name of each device for which they are the 
initial importer;
    (6) Manufactures components or accessories that are ready to be 
used for any intended health-related purpose and are packaged or 
labeled for commercial distribution for such health-related purpose, 
e.g. blood filters, hemodialysis tubing, or devices which of necessity 
must be further processed by a licensed practitioner or other qualified 
person to meet the needs of a particular patient, e.g., a manufacturer 
of ophthalmic lens blanks.
    (b) Registration or listing does not constitute an admission or 
agreement or determination that a product is a device within the 
meaning of section 201(h) of the act.
    (c) Registration and listing requirements shall not pertain to any 
person who acts as a wholesale distributor, as defined in Sec.  
807.3(t), and who does not manufacture, repackage, process, or relabel 
a device.
    (d) Owners and operators of establishments or persons engaged in 
the recovery, screening, testing, processing, storage, or distribution 
of human cells, tissues, and cellular and tissue-based products, as 
defined inSec.  1271.3(d) of this chapter, that are regulated under the 
Federal Food, Drug, and Cosmetic Act must register and list those human 
cells, tissues, and cellular and tissue-based products with the Center 
for Biologics Evaluation and Research on Form FDA 3356 following the 
procedures set out in subpart B of part 1271 of this chapter, instead 
of the procedures for registration and listing contained in this part, 
except that the additional listing information requirements of Sec.  
807.26 remain applicable.
    (e) Owners and operators of establishments that manufacture devices 
licensed under section 351 of the Public Health Service Act as well as 
licensed biological products used in the manufacture of a licensed 
device must register and list following the procedures set out in part 
607 of this chapter, instead of the procedures for registration and 
listing contained in this part.

Sec.  807.22  [Removed]

    4. Remove Sec.  807.22.

Sec.  807.21  [Redesignated as Sec.  807.22]

    5. Redesignate Sec.  807.21 as Sec.  807.22.

[[Page 14536]]

    6. Add new Sec.  807.21 to subpart B to read as follows:

Sec.  807.21  How to register establishments and list devices.

    (a) Owners or operators of establishments that are subject to the 
registration and listing requirements of this part must provide the 
following information to us using our electronic device registration 
and listing system, except as provided in paragraphs (b), (c), and (d) 
of this section:
    (1) Initial establishment registration information as required by 
Sec. Sec.  807.22(a) and 807.25;
    (2) Updates to registration information as required by Sec.  
807.22(b) and 807.25;
    (3) Initial device listing information as required by Sec.  
807.22(a), 807.25, and 807.28;
    (4) Updates to device listing information as required by Sec.  
807.22(b), 807.25, and 807.28, including updates to reflect the 
discontinuance or resumption of the commercial distribution of a 
previously-listed device as specified at paragraphs (d) and (e) of 
Sec.  807.28.
    (b) If the information under Sec.  807.21(a) cannot be submitted 
electronically, a waiver may be requested. Waivers will be granted only 
if use of electronic means is not reasonable for the person requesting 
the waiver. To request a waiver, applicants must send a letter to the 
Office of Compliance, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Building 66, rm. 
2621, Silver Spring, MD 20993-0002, that includes the following 
information:
    (1) The name and address of the device establishment(s) to be 
registered, a contact person for the owner or operator of the 
establishment, and the telephone number at which that person can be 
reached. If the establishment has already registered in the past, the 
letter should also include the owner or operator number, registration 
number, and any listing numbers previously assigned by FDA for that 
establishment.
    (2) Information about whether the company is an initial importer as 
defined in Sec.  807.3(g) and, if so, whether it also conducts any 
other activities or operations relating to devices.
    (3) A statement that use of the Internet is not reasonable for the 
person requesting the waiver, and an explanation of why such use is not 
reasonable. The statement must be signed by the owner or operator of 
the establishment, or by a person employed by the owner or operator who 
is authorized to make the declaration on behalf of the owner or 
operator.
    (c) Those owners or operators who have obtained a waiver from 
filing registration and listing information electronically should refer 
to Sec.  807.34 for information on how to submit such information by 
postal mail.
    (d) When additional device listing information (e.g., copies of 
labeling or advertisements) is requested by FDA as described at Sec.  
807.26(e), such information may be submitted by postal mail or 
electronically by e-mail, but will not be submitted using the FDA 
electronic device registration and listing system.
    7. Revise newly redesignated Sec.  807.22 to read as follows:

Sec.  807.22  Times for establishment registration and device listing.

    (a) Initial registration and listing. An owner or operator of an 
establishment who has not previously entered into an operation 
described in Sec.  807.20(a) shall register within 30 days after 
entering into such an operation and submit device listing information 
at that time.
    (b) Registration and listing updates. Owners or operators shall 
review and update all of their establishment registration and device 
listing information that is on file at FDA, documenting any changes 
that were not previously reported as follows:
    (1) Annual registration for each fiscal year is required for all 
establishments. Annual registration shall take place during the period 
beginning on October 1 and ending on December 31 of each fiscal year;
    (2) Updates to the registration information as described in Sec.  
807.25(b) shall be made within 30 days of any change to such 
information;
    (3) Every fiscal year, during the period beginning on October 1 and 
ending on December 31, owners or operators shall review and update all 
of their device listing information that is on file at FDA, reporting 
any changes or deletions to listings and any new listings that were not 
previously reported. The accuracy of all information on file must be 
confirmed each year regardless of whether any changes were made to the 
owner or operator's list of devices; and
    (4) Changes to listing information may also be made at other times, 
such as when a device is introduced into commercial distribution, when 
a change is made to a previously-listed device, or when a previously-
listed device is removed from commercial distribution.
    (c) Failure to submit any of the required information on time, as 
specified in paragraphs (a) and (b) of this section, will put the 
establishment in a ``failed to register'' or ``failed to list'' status 
as applicable. The establishment will not be considered active and the 
establishment registration and device listing information will not 
appear on the FDA Web site until such time as the owner or operator 
submits and FDA processes the required information.
    8. Revise Sec.  807.25 to read as follows:

Sec.  807.25  Information required for establishment registration and 
device listing.

    (a) All owners or operators that are subject to the registration 
and listing requirements of this part shall provide such information to 
us by using the FDA electronic device registration and listing system, 
unless granted a waiver from electronic submission in accordance with 
Sec.  807.21(b). Electronic submissions of registration and listing 
information must comply with part 11 of this chapter, except for the 
requirements in Sec.  11.10(b), (c), and (e), and the corresponding 
requirements in Sec.  11.30. Those owners or operators granted a waiver 
from electronic submission should refer to paragraphs (c) and (g) of 
this section and Sec.  807.34 for instructions on how to submit device 
registration and listing information.
    (b) Registration information required to be submitted includes: The 
name and mailing address of the device establishment; the Web site 
address of the device establishment, if any; the name, address, phone 
number, fax number, and e-mail address of the owner or operator; the 
name, address, phone number; fax number, and e-mail address of the 
establishment's official correspondent; and all trade names used by the 
establishment.
    (c) Owners or operators who have been granted a waiver from 
electronic filing must submit the establishment registration 
information described in paragraph (b) of this section, except for the 
Web site and e-mail address information, in paper form using the 
procedures set forth in Sec.  807.34.
    (d) Each owner or operator is required to maintain a listing of all 
officers, directors, and partners for each establishment registered by 
the owner or operator and to furnish this information to FDA upon 
request.
    (e) For each establishment, an official correspondent must be 
designated by the owner or operator to serve as a point of contact with 
FDA on matters relating to the registration of device establishments 
and the listing of device products. Each owner or operator shall also 
provide FDA with the name of a contact person at the owner or 
operator's offices who will be responsible for identifying the official 
correspondent for each establishment. The owner or operator contact 
person

[[Page 14537]]

will be the official correspondent in the event no one else has been 
properly designated. The official correspondent is responsible for:
    (1) Providing FDA with all required registration and listing 
information electronically unless a waiver from electronic submission 
has been granted in accordance with Sec.  807.21(b) ;
    (2) Receiving all correspondence from FDA concerning registration 
and listing;
    (3) Supplying, when requested by FDA, the names of all officers, 
directors, and partners; and
    (4) Receiving communications from FDA by e-mail, or by postal mail 
if the owner or operator has been granted a waiver from the requirement 
to file registration and listing information electronically.
    (f) The designation of an official correspondent does not in any 
manner affect the liability of the owner or operator of the 
establishment or any other individual under section 301(p) or any other 
provision of the act.
    (g) Device listing information must be submitted to FDA 
electronically unless a waiver from electronic submission has been 
granted in accordance with Sec.  807.21(b). Owners or operators who 
have been granted a waiver must submit the required device listing 
information, including information required by this paragraph, Sec.  
807.28, and any listing information requested by FDA under Sec.  
807.26(e), in paper form using the procedures set forth in Sec.  
807.34. The information required for each device listed includes:
    (1) The current registration number and name of each establishment 
under the ownership and control of the owner or operator where the 
device is manufactured, repackaged, relabeled, or otherwise processed, 
or where specifications are developed.
    (2) The product code for each device that is exempt from premarket 
notification and approval or which was in commercial distribution prior 
to May 28, 1976.
    (3) The proprietary or brand name(s) under which each device is 
marketed.
    (4) The FDA-assigned premarket submission number of the approved 
application, cleared premarket notification, or approved humanitarian 
device exemption for each device listed that is subject to sections 
505, 510, 515, or 520 of the act, which includes devices that are not 
exempt from premarket notification and approval.
    (5) Each activity or process that is conducted on or done to the 
device at each establishment, such as manufacturing, repacking, 
relabeling, developing specifications, remanufacturing, single-use 
device reprocessing, contract manufacturing, contract sterilizing, or 
manufacturing for export only.

Sec.  807.26  [Removed and Reserved]

    9. Remove and reserve Sec.  807.26.

Sec.  807.31  [Redesignated as Sec.  807.26]

    10. Redesignate Sec.  807.31 as Sec.  807.26.
    11. Amend newly redesignated Sec.  807.26 by adding paragraph (f) 
to read as follows:

Sec.  807.26  Additional listing information.

* * * * *
    (f) Labeling, advertisements, and other information to be submitted 
upon request in accordance with paragraph (e) of this section may be 
submitted by postal mail or electronically by e-mail, but will not be 
submitted using the FDA electronic device registration and listing 
system. Electronic submissions of such information must comply with 
part 11 of this chapter, except for the requirements in Sec.  11.10 
(a), (c) through (h), and (k), and the corresponding requirements in 
Sec.  11.30. The information provided in electronic format must be in a 
form that we can process, review, and archive.

Sec.  807.30  [Redesignated as Sec.  807.28]

    12. Redesignate Sec.  807.30 as Sec.  807.28.
    13. Revise newly redesignated Sec.  807.28 to read as follows:

Sec.  807.28  Updating device listing information.

    (a) Updating of device listing information is required when an 
additional establishment begins to engage in any of the activities 
described in Sec.  807.3(d) with respect to a listed device, such as 
manufacturing, developing specifications, repackaging, relabeling, or 
otherwise processing the device. Updating of the listing is also 
required when an establishment begins performing another activity on or 
to the device, or ceases to perform an activity on or to the device 
that had previously been identified on the device listing.
    (b) An owner or operator shall create a new device listing using 
the FDA electronic device registration and listing system:
    (1) When introducing into commercial distribution an exempt device 
identified with a product code that is not currently listed by the 
owner or operator; or
    (2) When introducing into commercial distribution a non-exempt 
device with an FDA premarket submission number that is not currently 
listed by the owner or operator.
    (c) All device listings for foreign establishments must be 
submitted before the device may be imported or offered for import into 
the United States.
    (d) An owner or operator who discontinues commercial distribution 
of a device shall discontinue the device listing using the FDA 
electronic device registration and listing system. A device listing is 
considered discontinued if:
    (1) All devices under an exempt product code have been discontinued 
or
    (2) All devices associated with an FDA premarket submission number 
have been discontinued.
    (e) If commercial distribution of a discontinued device is resumed, 
the owner or operator must reactivate the previously-discontinued 
listing using the electronic device registration and listing system. 
Any changes to the listing information for the product that is the 
subject of the listing such as a new establishment, new activity, or 
new proprietary name must be made using the electronic device 
registration and listing system at the time the listing is reactivated.
    (f) FDA will assign one listing number for all devices exempt from 
premarket notification requirements under a single product code. For 
products not exempt from premarket notification requirements, a single 
listing number will be assigned by FDA for each FDA premarket 
submission number.
    14. Add Sec.  807.34 to subpart B to read as follows:

Sec.  807.34  Summary of requirements for owners or operators granted a 
waiver from submitting required information electronically.

    (a) For initial registration and listing, owners or operators who 
have been granted a waiver from electronic filing using the procedures 
set forth in Sec.  807.21(b) must send a letter containing all of the 
registration and listing information described in Sec. Sec.  807.22, 
807.25, (and Sec.  807.26 when such information is requested by FDA), 
at the times described in Sec.  807.22, to: The Office of Compliance, 
Center for Devices and Radiological Health (HFZ-308), Food and Drug 
Administration, 10903 New Hampshire Ave., Building 66, room 3521, 
Silver Spring, MD 20993-0002.
    (b) As specified in Sec.  807.22(b)(1) and (b)(3), all owners or 
operators shall update their establishment registration and device 
listings annually during the period beginning on October 1 and ending 
on December 31 of each fiscal year.
    (c) Failure to submit any of the required information on time, as 
specified in Sec.  807.22(a) and (b), will put the establishment in a 
``failed to register'' or ``failed to list'' status as applicable.

[[Page 14538]]

The establishment will not be considered active and the establishment 
registration and device listing information will not appear on the FDA 
Web site until the required information is submitted to and processed 
by FDA.
    15. Amend Sec.  807.35 by revising paragraphs (a) and (b) to read 
as follows:

Sec.  807.35  Notification of registrant.

    (a) FDA will assign each device establishment a permanent 
registration number after verifying the initial establishment 
registration information that has been submitted. The owner or operator 
of the establishment will also be assigned an identifying number. Both 
numbers will be sent to the official correspondent by e-mail, or by 
postal mail if the owner or operator has been granted a waiver from the 
requirement to file registration and listing information 
electronically.
    (b) Owners or operators of device establishments who also 
manufacture or process biological products (including devices licensed 
under section 351 of the Public Health Service Act) or drug products at 
the same establishment must also register and list those products under 
part 607 or part 207 of this chapter, as appropriate. Registration and 
listing for human blood and blood products, devices licensed under 
section 351 of the Public Health Service Act, and licensed biological 
products used in the manufacture of a device licensed under section 351 
of the Public Health Service Act, are subject to part 607 of this 
chapter; registration and listing for all other drug products 
(including other biological products that are also regulated as drug 
products) are subject to part 207 of this chapter.
* * * * *
    16. Revise Sec.  807.37 to read as follows:

Sec.  807.37  Public availability of establishment registration and 
device listing information.

    Establishment registration and device listing information is 
available for public inspection in accordance with section 510(f) of 
the act and will be posted on the FDA Web site. Requests for 
information by persons who do not have access to the Internet should be 
directed to the Office of Compliance, Center for Devices and 
Radiological Health (HFZ-308), Food and Drug Administration, 10903 New 
Hampshire Ave., Building 66, rm. 3521, Silver spring, MD 20993-0002. In 
addition, there will be available for inspection at each of the Food 
and Drug Administration district offices the same information for firms 
within the geographical area of such district offices. Upon request, 
verification of a registration number or location of a registered 
establishment will be provided.
    17. The heading of subpart C is revised to read as set forth below:

Subpart C--Procedures for Foreign Device Establishments

    18. Amend Sec.  807.40 by revising paragraphs (a) and (c) and by 
adding paragraph (d) to read as follows:

Sec.  807.40  Establishment registration and device listing for foreign 
establishments importing or offering for import devices into the United 
States.

    (a) Any establishment within any foreign country engaged in the 
manufacture, preparation, propagation, compounding, or processing of a 
device that is imported or offered for import into the United States 
shall register such establishment and list such devices using the FDA 
electronic device registration and listing system in conformance with 
the procedures in this section, Sec.  807.41, and subpart B of this 
part. The official correspondent for the foreign establishment shall 
facilitate communication between the foreign establishment's management 
and representatives of the Food and Drug Administration for matters 
relating to the registration of device establishments and the listing 
of device products.
* * * * *
    (c) No device may be imported or offered for import into the United 
States unless it is the subject of a device listing as required under 
subpart B of this part and is manufactured, prepared, propagated, 
compounded, or processed at a registered foreign establishment; 
however, this restriction does not apply to devices imported or offered 
for import under the investigational use provisions of part 812 of this 
chapter.
    (d) The establishment registration and device listing information 
shall be in the English language.
    19. Add Sec.  807.41 to subpart C to read as follows:

Sec.  807.41  Identification of importers and persons who import or 
offer for import.

    (a) Upon initial registration, annually, and at the time of any 
changes, each foreign establishment required to register and list as 
provided in Sec.  807.40(a) must, using the FDA electronic device 
registration and listing system, submit the name, address, telephone 
and fax numbers, e-mail address, and registration number, if any has 
been assigned, of any importer (defined in Sec.  807.3(x)) of the 
establishment's devices that is known to the foreign establishment. The 
foreign establishment must also specify which of the establishment's 
listed products each importer receives from the foreign establishment.
    (b) Upon initial registration, annually, and at the time of any 
changes, each foreign establishment required to register and list as 
provided in Sec.  807.40(a) must, using the FDA electronic device 
registration and listing system, submit the name, address, telephone 
and fax numbers, e-mail address, and registration number, if any has 
been assigned, of each person who imports or offers for import the 
establishment's devices into the United States. The term ``person who 
imports or offers for import,'' which is defined in Sec.  807.3(y), 
includes agents, brokers, or other parties used by the foreign 
establishment to facilitate the import of its device into the United 
States.
    (c) For each individual or organization identified by the foreign 
establishment under paragraphs (a) and (b) of this section, the foreign 
establishment must submit to FDA electronically the current FDA 
premarket submission number (e.g., PMA, 510(k), HDE, NDA) and any other 
identifying information that is known to the establishment for each 
device being imported or offered for import by the named individuals or 
organizations.

    Dated: March 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-6662 Filed 3-25-10; 8:45 am]
BILLING CODE 4160-01-S