Document ID: FDA-2008-N-0393-0001
Agency: fda
Document Type: Proposed Rule
Title: Medical Device Reporting: Electronic Submission Requirements
Posted Date: 2009-08-21T04:00Z

[Federal Register: August 21, 2009 (Volume 74, Number 161)]
[Proposed Rules]               
[Page 42203-42217]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21au09-11]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 803

[Docket No. FDA-2008-N-0393]
RIN 0910-AF86

 
Medical Device Reporting: Electronic Submission Requirements

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its postmarket medical device reporting regulation to require that 
manufacturers, importers, and user facilities submit mandatory reports 
of individual medical device adverse events, also known as medical 
device reports (MDRs) to the agency in an electronic format that FDA 
can process, review, and archive. Mandatory electronic reporting would 
improve the agency's process for collecting and analyzing postmarket 
medical device adverse event information. The proposed regulatory 
changes would provide the agency with a more efficient data entry 
process that would allow for timely access to medical device adverse 
event information and identification of emerging public health issues. 
Elsewhere in this issue of the Federal Register, FDA is also announcing 
a draft guidance document that provides recommendations on how to 
prepare and submit electronic MDRs to FDA in a manner that satisfies 
the requirements

[[Page 42204]]

of this proposed regulation. The proposal also includes modifications 
to the regulations specifying the content of required MDRs to better 
track information already solicited on the FDA Form 3500A.

DATES: November 19, 2009. Submit comments on information collection 
issues under the Paperwork Reduction Act of 1995 (the PRA) by September 
21, 2009, (see the ``Paperwork Reduction Act of 1995'' section of this 
document).

ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0393 and/or RIN number 0910-AF86, 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) (see the 
``Paperwork Reduction Act of 1995'' section of this document).
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.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal, as described previously, in the ADDRESSES portion 
of this document under Electronic Submissions.
    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(s), 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.
    Information Collection Provisions: The information collection 
provisions of this proposed rule have been submitted to OMB for review. 
Interested persons are requested to fax or e-mail comments regarding 
the information collection provisions by September 21, 2009, to the 
Office of Information and Regulatory Affairs, OMB. To ensure that 
comments on information collection are received, OMB recommends that 
written comments be faxed to 202-395-7285 or e-mailed to OIRA_
submission@omb.eop.gov. Please reference this proposed rule and OMB 
Control Number 0910-0437 and mark your comments to the Attention of the 
FDA Desk Officer.

FOR FURTHER INFORMATION CONTACT: Howard Press, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Building 66, rm. 3320, Silver Spring, MD 20993-0002, 301-796-
6087.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Introduction
    A. What Are the Medical Device Reporting Requirements?
    1. What Are the Current Reporting Requirements for Manufacturers 
and What Is Their Status?
    2. What Are the Current Reporting Requirements for Importers?
    3. What Are the Current Reporting Requirements for User Facilities?
    B. What Format Is Currently Used for Submitting Postmarket Medical 
Device Reports?
    C. Why Is FDA Proposing to Require Electronic Submissions of MDRs?
    1. What Are the Options for Electronic Reporting?
    2. What Is the FDA Electronic Submission Gateway (ESG)?
    3. How Do I Know FDA Received My Electronic Submission and It Was 
Successfully Processed?
II. Description of the Proposed Rule
    A. How Would the Rule Address Submission of Reports in Electronic 
Format?
    1. How Would the Reporting Requirements for Manufacturers Change 
With Respect to Electronic Format?
    2. How Would the Reporting Requirements for Importers Change With 
Respect to Electronic Format?
    3. How Would the Reporting Requirements for User Facilities Change 
With Respect to Electronic Format, and How Would Annual Report 
Requirements be Affected?
    4. How Would the Requirement to Submit Reports in Electronic Format 
Affect Recordkeeping Requirements?
    B. How Would I Submit MDRs in Electronic Format?
    C. How Can a Medical Device Manufacturer, Importer, or User 
Facility Obtain a Variance Regarding the Requirement to Submit a Report 
in Electronic Format?
    D. What Other Changes Are Being Proposed?
    E. When Would the Rule Become Effective?
III. What Is the Legal Authority for This Rule
IV. Is There an Environmental Impact?
V. Analysis of Impacts
    A. Benefits
    B. Costs
    1. One-Time Costs
    a. Rewriting SOPs and training personnel
    b. Setting up systems for submission
    c. Electronic certificates
    2. Annual costs
    a. Maintaining electronic certificates
    b. High-speed Internet access
    C. Summary of Benefits and Costs
    D. Alternatives Considered
    E. Regulatory Flexibility Analysis
VI. Paperwork Reduction Act of 1995
    A. Reporting Requirements
    B. Recordkeeping Requirements
    C. Total Annual Cost Burden
VII. Federalism
VIII. Request for Comments
IX. References

I. Introduction

    In this proposal, we provide background information on the current 
status of FDA's medical device reporting requirements, explain the 
revisions we are proposing here, and describe our approach to 
electronic medical device reporting.
    For over 20 years, FDA has received postmarket MDRs in a paper 
format. This proposed rule to require the electronic submission to FDA 
of most MDRs is an important step towards improving the agency's 
systems for collecting and analyzing postmarket MDRs. The proposed rule 
includes reports of deaths, serious injuries, and malfunctions that 
must be reported to FDA in initial 5-day, 10-day, or 30-day individual 
MDRs or in supplemental reports. We believe this proposed rule would 
have the following benefits:
     Reduce industry's time and costs associated with 
transcribing data from internal data management systems to paper and 
mailing the paper reports to the agency,

[[Page 42205]]

     Eliminate the agency's transcription errors, time, and 
costs associated with receiving paper reports and transcribing data to 
electronic format for review and analysis,
     Expedite the agency's access to safety information in a 
format that would support more efficient and comprehensive data 
analysis and reviews, and
     Enhance the agency's ability to rapidly communicate 
information about suspected problems to the medical device industry, 
health care providers, consumers, and other government agencies.
    In addition, this proposed rule is consistent with the Government 
Paperwork Elimination Act (Public Law 105-277) requirement that Federal 
agencies allow individuals or entities to submit information or 
transact business with the agency electronically.

A. What Are the Medical Device Reporting Requirements?

    The requirements of current medical device reporting regulations 
are summarized in sections I.A.1 to I.A.3 of this document. In 
addition, we address changes to these regulations to be effected 
outside of this proposed rule.
    Current MDR regulations (part 803 (21 CFR part 803)) require 
manufacturers and importers of marketed medical devices, and user 
facilities, to submit postmarket reports of individual medical device 
adverse events to FDA on the FDA Form 3500A.
1. What Are the Current Reporting Requirements for Manufacturers and 
What Is Their Status?
    The current MDR regulation requires that manufacturers of medical 
devices submit a postmarket MDR of an individual adverse event no later 
than 30 calendar days after becoming aware of information that a device 
the manufacturer markets may have caused or contributed to a death, 
serious injury, or malfunction (Sec.  803.50). This report must be 
submitted on the FDA Form 3500A, (Sec.  803.20), and contain 
information described in Sec.  803.52.
    In addition, the regulation requires manufacturers to provide 
supplemental information about such events, on an FDA Form 3500A, 
within 30 calendar days of obtaining information should such 
information become available after the initial MDR was filed with FDA 
(Sec.  803.56). In instances where the medical device adverse event 
resulted in remedial action to prevent an unreasonable risk of 
substantial harm to the public health, or at the discretion of the 
agency, the regulation requires the manufacturer to submit an MDR to 
the agency no later than 5 working days after becoming aware of the 
information (Sec.  803.53).
    Title II, section 227, of the Food and Drug Administration 
Amendments Act of 2007 (FDAAA) (Public Law 110-85), amended section 519 
of the Federal Food, Drug, and Cosmetic Act (the act) to require that 
FDA establish criteria for manufacturer reports of malfunctions for 
most class I and certain class II devices that include requiring those 
reports to be in summary form and made on a quarterly basis. The types 
of events required to be reported are unchanged. FDA intends to address 
changes necessitated by this statutory change separately from this 
proposed rule, and will address requirements for submission of those 
new summary malfunction reports at that time. However, some individual 
malfunction reports will continue to be required even after the FDAAA-
related changes, and as explained below, the rule proposed here does 
address submission of individual malfunction reports to the agency.
2. What Are the Current Reporting Requirements for Importers?
    The MDR regulation requires that importers of medical devices 
submit a postmarket MDR to the agency and the manufacturer no later 
than 30 calendar days after becoming aware of information that 
reasonably suggests that one of the importer's marketed devices may 
have caused or contributed to a death or serious injury (Sec.  
803.40(a)). Importers must submit reports to the manufacturer no later 
than 30 calendar days after becoming aware of information that 
reasonably suggests that one of the importer's marketed devices has 
malfunctioned and that this device or a similar device marketed by the 
importer would be likely to cause or contribute to a death or serious 
injury if the malfunction were to recur (Sec.  803.40(b)). These 
reports must be submitted on the FDA Form 3500A (see Sec.  803.20) and 
contain the information specified in Sec.  803.42.
3. What Are the Current Reporting Requirements for User Facilities?
    The MDR regulation requires that user facilities submit a 
postmarket MDR of death to the agency and an MDR of death or serious 
injury to the device manufacturer within 10 working days of becoming 
aware of information that reasonably suggests that a device has or may 
have caused or contributed to the death or a serious injury of a 
patient of the facility. (Sec.  803.30(a)). The regulation requires 
that user facilities submit postmarket reports of serious injury to the 
agency within 10 working days if the manufacturer of the device is 
unknown or cannot be identified (Sec.  803.30(a)(2)). These reports 
must be submitted on the FDA Form 3500A (see Sec.  803.20(a)), and 
include the information described in Sec.  803.32.
    In addition, user facilities are required to submit to the agency 
an annual summary of the reports they sent to manufacturers and the 
FDA, using FDA Form 3419 (Sec.  803.33). The proposal to require 
submission of reports to FDA in an electronic format does not apply to 
user facility annual reports made under Sec.  803.33, although other 
changes to Sec.  803.33 are proposed as explained in section I.B of 
this document.

B. What Format Is Currently Used for Submitting Postmarket Medical 
Device Reports?

    Current regulations at Sec.  803.20(a) require that user 
facilities, importers, and manufacturers use the FDA Form 3500A to 
submit mandatory reports about FDA-regulated devices. This requirement 
took effect July 31, 1996 (see 60 FR 63578, December 11, 1995; 61 FR 
16043, April 11, 1996).
    Certain blocks of the FDA Form 3500A are required only for user 
facilities, while others are required only for manufacturers (see Sec.  
803.20(a)(2)).
    Subsequent to its initial adoption, FDA revised the Form 3500A and 
its instructions, adding elements including the premarket approval 
application (PMA) or 510(k) number for the device, and two questions 
regarding reprocessed single-use devices. The agency was required to 
revise the form to include the questions regarding reprocessed single-
use devices under section 303 of the Medical Device User Fee and 
Modernization Act of 2002 (Public Law 107-250). The revised FDA Form 
3500A is approved under the PRA, under OMB control number 0910-0291.
    FDA Form 3500A has been routinely completed on paper and 
transmitted to FDA by mail, requiring FDA to manually input information 
from those reports into its internal electronic systems before it can 
be reviewed and analyzed. This process is extremely time consuming, 
costly, and susceptible to data entry errors. Because FDA regulations 
at Sec.  803.14 provide for the possibility of voluntary electronic 
submission of MDRs, with agency permission, several regulations in part 
803 refer to submission of reports using the FDA Form 3500A ``or an 
electronic equivalent approved under section 803.14.'' (See, e.g., 
Sec. Sec.  803.30, 803.40, and 803.53.) However, reporters have not 
made use of section 803.14 to

[[Page 42206]]

pursue voluntary electronic submission of MDRs, and FDA's legacy 
systems were not in general designed to accept submission of MDRs in 
electronic format.

C. Why Is FDA Proposing to Require Electronic Submission of MDRs?

    When a medical device has been cleared for marketing and enters the 
market, the product is introduced to a larger patient population in 
settings different from clinical trials. New information generated 
during the postmarketing period offers further insight into the 
benefits or risks of the product, and evaluation of this information is 
important for all products to ensure their safe use. Historically, FDA 
has received almost all postmarket MDRs on paper through the mail. When 
data elements are provided to FDA on only paper, the information must 
be entered by hand into an electronic format for review and analysis. 
This process is extremely time consuming, costly, and susceptible to 
data entry errors.
    The electronic submission of medical device reports would lead to 
more efficient reviews, enhancing our ability to rapidly disseminate 
significant information to the medical device industry, health care 
providers, and consumers, in support of FDA's public health mission.
    Electronic submissions would also improve the speed and efficiency 
of both industry and agency operations. Electronic reporting can 
benefit industry by reducing the costs associated with collating, 
copying, storing, retrieving, and mailing paper medical device reports 
to the agency on FDA Form 3500A. In addition, the agency benefits from 
the elimination of manual data entry processes and reductions in 
physical storage for paper copies of the FDA Form 3500A. Based on low 
rates of participation in prior pilot voluntary electronic MDR 
submission programs, FDA believes that without a regulation requiring 
electronic submission of MDRs a large number of medical device firms 
and user facilities would resist changing their procedures for a long 
period of time. This delay would hinder our achieving the benefits of 
standardized formats and quicker access to MDR data.
1. What Are the Options for Electronic Reporting?
    FDA's Center for Devices and Radiological Health (CDRH) has 
established its MDR databases currently to support two options for 
electronic submission of MDRs: One designed for low volume reporting 
and one designed for high volume reporting. Both options make use of 
the FDA Electronic Submission Gateway (FDA ESG), a secure electronic 
portal described further in this document, for transmission of reports 
to FDA. In accordance with 21 CFR 11.2(b), CDRH is now accepting on a 
voluntary basis, in lieu of paper, MDRs prepared and transmitted in 
accordance with these options. More information on electronic 
submission of MDRs is available at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/PostmarketRequirements/
ReportingAdverseEvents/ucm127932.htm.
    For low-volume medical device reporting (few or infrequent MDRs), 
the current approach developed by the agency uses the CDRH eSubmitter 
(CeSub) software. The CeSub software allows for the submission of one 
MDR at a time. The software provides the following tools:
     Save address and contact information,
     Search for a Product Code,
     Search to locate a patient or Device Problem Code,
     Search to find manufacturer evaluation codes (method, 
result, and conclusion),
     Attach documents when additional information needs to be 
provided,
     Produce a ``missing data report'' to help ensure that all 
required information is supplied before submission to FDA.
    Once the MDR is completed, the file is ``packaged for submission.'' 
The package generates an electronic version of the FDA Form 3500A, 
which can be submitted to FDA using the FDA ESG. The final CeSub-
generated report can also be saved or printed, for recordkeeping or to 
provide reports to manufacturers or other entities outside of FDA. The 
CeSub software and instructions for installation are free and available 
at: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm. We may 
sometimes update or change our methodology, approach or software to 
improve the low-volume reporting experience.
    Reporters with large volumes of MDRs may prefer the second option, 
called the Health Level 7 Individual Case Safety Report (HL7 ICSR). The 
HL7 ICSR was developed in conjunction with the HL7 standards 
organization to support the exchange of electronic data. This option 
allows for the extraction directly from the reporter's database of 
information to populate an MDR, production of the appropriate data 
output, and transmission of the MDRs to the FDA ESG. The HL7 ICSR 
supports the batch submission of more than one individual MDR at a 
time. Reporters developing applications using the HL7 ICSR standard may 
also build functions for saving or printing those reports.
    The draft guidance document announced elsewhere in this Federal 
Register provides information on both options for electronic submission 
of MDRs.
2. What Is the FDA Electronic Submission Gateway (ESG)?
    The FDA ESG is the entry point for all electronic submissions to 
the agency. The FDA ESG is available 24 hours a day, 7 days a week. 
Information on the FDA ESG is available at http://www.fda.gov/
ForIndustry/ElectronicSubmissionsGateway/default.htm. To use the FDA 
ESG, reporters need to have a digital certificate. A digital 
certificate is an attachment to an electronic message that allows the 
recipient to authenticate the identity of the sender via third party 
verification from an independent certificate authority. Digital 
certificates are used to identify encryption and decryption codes 
between message senders and recipients. Information on digital 
certificates can be found at http://www.fda.gov/ForIndustry/
ElectronicSubmissionsGateway/ucm113223.htm.
3. How Do I Know FDA Received My Electronic Submission and It Was 
Successfully Processed?
    FDA's electronic submission processing system sends the submitter 
three different acknowledgments (messages) for each submission. 
Acknowledgment 1 comes from the ESG and indicates your submission was 
received. Acknowledgment 2 is sent by the ESG and indicates the 
submission reached CDRH. CDRH sends Acknowledgment 3 and notifies you 
whether your submission was successfully loaded into CDRH's adverse 
event database or the submission contained errors (specified in the 
acknowledgment) during validation and loading. If your submission 
contained errors, the errors need to be corrected and the corrected 
reports resent.

II. Description of the Proposed Rule

A. How Would the Rule Address Submission of Reports in Electronic 
Format?

    This rule would revise Sec.  803.12 to require that manufacturers, 
importers, and user facilities submit postmarket MDRs to the agency in 
an electronic format that FDA can process, review, and archive. Under 
the proposal, FDA will periodically issue information on

[[Page 42207]]

file formats, preparation and organization of files, media, method of 
transmission, and other relevant technological specifications for 
providing reports in an electronic format that FDA can process, review, 
and archive. Proposed new Sec.  803.23 would direct reporters to the 
agency's Web site to find the most updated relevant information. 
Reports between manufacturers, importers, and user facilities would not 
be subject to the requirement of submission in electronic format, and 
may be in any format the recipient can read.
    The rule would make conforming changes throughout part 803 to 
reflect the proposed requirement to submit reports to FDA in electronic 
format. These changes include removing Sec.  803.11, which currently 
addresses obtaining paper forms, and removing Sec.  803.14, which 
currently provides for voluntary electronic submission of reports with 
FDA consent. The proposal would amend Sec.  803.19, which already 
addresses exemptions or variances from any of the requirements of part 
803, to specifically address exemption or variance from the requirement 
to submit reports to FDA in electronic format. Other changes include 
removing references to ``electronic equivalent[s] approved under Sec.  
803.14'' from Sec. Sec.  803.13, 803.30, 803.33, 803.40, and 803.53, 
and updating wording in Sec.  803.20 and 803.56 to be more consistent 
with the fact that reports will not be submitted on paper (and thus, 
for example, would no longer have a front and back).
    If this proposed rule becomes final, manufacturers, importers, and 
user facilities would be required to begin submitting medical device 
reports to the agency in electronic format no later than 1 year from 
the date of publication of a final rule. After the effective date, the 
agency would not accept MDRs submitted on paper copies of the FDA Form 
3500A, or in electronic formats other than those identified as ones 
that FDA can process, review, and archive in information provided in 
conjunction with this rule, unless the agency had granted an exemption 
or variance as provided for in Sec.  803.19.
1. How Would the Reporting Requirements for Manufacturers Change With 
Respect to Electronic Format?
    The rule would amend Sec. Sec.  803.50(a), 803.53, and 803.56 to 
require submission of information required by Sec. Sec.  803.52, 
803.53, and 803.56 in electronic format in accordance with Sec.  
803.12(a).
2. How Would the Reporting Requirements for Importers Change With 
Respect to Electronic Format?
    The proposed rule amends Sec.  803.40(a) to require submission to 
FDA of information required by Sec.  803.42 in electronic format in 
accordance with Sec.  803.12(a). The proposed electronic format 
requirement does not extend to importer reports submitted to device 
manufacturers, which may be in any format that the recipient can read.
3. How Would the Reporting Requirements for User Facilities Change With 
Respect to Electronic Format, and How Would Annual Report Requirements 
be Affected?
    The proposed rule amends Sec.  803.30(a) to require submission to 
FDA of information required by Sec.  803.32 in electronic format in 
accordance with Sec.  803.12(a). The amendment does not impose 
mandatory electronic format requirements on user facility reports 
submitted to device manufacturers, which may be provided in any format 
the recipient can read.
    The proposed rule also makes certain changes to Sec.  803.33, 
addressing user facility annual reports. Under the proposed rule, user 
facilities will continue to submit annual reports on the paper FDA Form 
3419. Because the proposal to require submission of individual adverse 
events reports in electronic format calls for amendments to Sec.  
803.12 and for removal of Sec. Sec.  803.11 (indicating how to obtain 
paper forms) and 803.14 (addressing voluntary electronic submissions), 
FDA is proposing to amend Sec.  803.33 to specify where to obtain the 
FDA Form 3419, where to submit completed reports under that section, 
and to remove references to Sec.  803.14.
4. How Would the Requirement to Submit Reports in Electronic Format 
Affect Recordkeeping Requirements?
    Section 803.18 of the regulation addresses requirements for 
establishing and maintaining MDR files or records for manufacturers, 
user facilities, and importers. FDA is proposing to amend Sec.  
803.18(b)(ii) to require that MDR files contain copies of all reports 
submitted under part 803, whether paper or electronic. As under the 
current regulations, under the proposal, regulated entities may choose 
to maintain required records either in hard copy, by printing out 
reports submitted in electronic format, or in electronic form. (For 
information regarding FDA's current thinking and enforcement policy 
with regard to requirements for maintaining electronic records, see 21 
CFR part 11 and the agency guidance document, ``Guidance for Industry: 
Part 11, Electronic Records; Electronic Signatures--Scope and 
Application,'' available at http://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/
ucm072322.pdf5667fnl.pdf.). FDA is also proposing to add Sec.  
803.18(b)(1)(iii) to require the retention of all acknowledgments FDA 
sends the manufacturer, importer, or user facility when reports are 
submitted in electronic format, which will indicate the timing and 
success of submission.

B. How Would I Submit MDRs in Electronic Format?

    As noted previously, if the proposed rule is finalized, 
manufacturers, importers, and user facilities will be required to 
submit most MDRs to the agency in an electronic format that FDA can 
process, review, and archive. In order to best accommodate 
technological changes, FDA expects to issue information on how to 
prepare and submit MDRs to the agency in a way that would satisfy the 
requirements of this proposed rule. The most specific and updated 
information about how to create, format, and transmit reports, using 
the CeSub software (designed for low volume reporting) or the HL7 ICSR 
(designed for high volume reporting), is provided on the agency's Web 
site, at the address provided in proposed Sec.  803.23. The agency will 
make every effort to maintain backwards compatibility when implementing 
changes to the systems and formats for electronic submission. When 
backwards compatibility is not possible, the agency will provide public 
notice with a duration commensurate with the complexity of the change.

C. How Can a Medical Device Manufacturer, Importer, or User Facility 
Obtain a Variance Regarding the Requirement to Submit a Report in 
Electronic Format?

    Under proposed Sec.  803.19, a manufacturer, importer, or user 
facility may submit a written request to FDA seeking a variance of the 
Sec.  803.12 requirement to submit reports to the agency in an 
electronic format that the agency can process, review, and archive. 
Written requests must contain the reason(s) why the reporting entity 
requires a variance and for how long the variance is needed. FDA 
anticipates receiving few variance requests because of the availability 
of the Internet and the commercial availability of digital certificates 
as well as FDA's free CeSub Internet software. Under the proposal, if 
FDA grants a variance, the

[[Page 42208]]

manufacturer, importer, or user facility would be required to submit 
MDRs as specified by FDA in the letter authorizing the variance.

D. What Other Changes Are Being Proposed?

    The proposed rule would also codify the following modifications:
    1. FDA proposes to remove the definition of ``Five-day report'' in 
Sec.  803.3, which merely referred to a report submitted under Sec.  
803.53 (the only provision of the regulation in which the term 
appears), using the FDA Form 3500A or ``an electronic equivalent 
approved under Sec.  803.14.'' Because this definition is not 
necessary, FDA proposes to remove it.
    2. FDA proposes to amend Sec. Sec.  803.32, 803.42, and 803.52 to 
make minor wording changes and corrections to these sections to reflect 
modifications already made to FDA Form 3500A and its instructions, with 
OMB approval under the PRA. For example, section 303 of the Medical 
Device User Fee and Modernization Act of 2002 (Public Law 107-250) 
required FDA to modify the forms to facilitate reporting of MDRs 
involving single-use devices that have been reprocessed for reuse (see 
69 FR 7491, February 17, 2004). FDA is proposing to amend Sec. Sec.  
803.32, 803.42, and 803.52 to reflect the addition to the FDA Form 
3500A of these two questions concerning whether the device is a single 
use device that has been reprocessed and reused on a patient and the 
name and address of the reprocessor.
    FDA is also proposing to change Sec. Sec.  803.32(b)(4), 
803.42(b)(4), and 803.52(b)(4) from ``date of report by the initial 
reporter'' to ``date of this report.'' This change would make part 803 
consistent with the way that other FDA Centers interpret FDA Form 
3500A, Block B4 and how Block B4 appears on FDA Form 3500A. Finally, 
FDA is also proposing to make other minor updates to Sec. Sec.  
803.32(c), 803.42(c), and 803.52(c) and (e) to reflect the changes 
already made to the forms and instructions, including a reference to 
the product code and PMA/510(k) number.

E. When Would the Rule Become Effective?

    FDA proposes that any final rule that issues based on this proposal 
become effective 1 year after the date the final rule publishes in the 
Federal Register.

III. What Is the Legal Authority for This Rule?

    FDA's legal authority to amend its regulations governing the 
submission of postmarket medical device adverse event reports for 
medical devices derives from 21 U.S.C. 352, 360, 360i, 360j, 371, and 
374.

IV. Is There an 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.

V. Analysis of 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). This proposed rule has 
been determined to be a significant regulatory action.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because we lack information on the electronic 
submission capabilities of all the firms potentially affected by this 
proposed rule we have not proposed to certify that the proposed rule 
would not have a significant economic impact on a substantial number of 
small entities. We request commenters to submit such information in 
their comments.
    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 $133 million, using the most current (2008) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any 1-year expenditure that will meet or 
exceed this amount.
    The purpose of this proposed rule is to require the submission of 
MDRs in an electronic format the agency can process, review, and 
archive. It would affect all persons subject to medical device 
reporting under part 803, which includes medical device manufacturers, 
device importers, and user facilities.
    The proposed rule is part of a greater agency initiative to adopt 
electronic technologies to improve the quality of our operations and 
increase the efficiency of our resources. The rule would reduce FDA's 
current costs associated with processing medical device reports (or 
MDRs) that are received on the paper FDA Form 3500A. By receiving MDRs 
electronically, FDA would be able to access the adverse event 
information more quickly and also eliminate potential data entry errors 
that could occur during input transcription of the information from the 
paper FDA Form 3500A reports into our electronic medical device adverse 
event reporting database.
    After considering various alternatives, FDA determined that without 
this regulation, the agency will need to maintain adequate resources to 
continue to convert paper 3500A MDRs to electronic MDR records until 
all manufacturers, importers, and user facilities voluntarily adopted 
the proposed electronic submission format, possibly years in the 
future.

A. Benefits

    The major benefit of this proposed rule would be to public health 
because the agency would have quicker access to the medical device 
adverse event reports information and thus could more quickly identify 
and act on any medical device problems. Currently, FDA receives 100,000 
initial MDRs annually on the paper FDA Form 3500A, which are manually 
entered into the FDA database. FDA receives an additional 110,000 
supplemental reports each year that are also submitted on the paper FDA 
Form 3500A and need to be processed and entered into the FDA database. 
It can take from 3 days to more than 6 months before an MDR submitted 
on a paper copy of the FDA Form 3500A may be available for analysis in 
the Manufacturer and User Device Experience database (MAUDE). With a 
standardized electronic format, medical device reports would become 
available for analysis as soon as they are processed into MAUDE. With a 
reduction in the time to manually enter the MDRs into the MAUDE 
database, analysis and action, including feedback to manufacturers and 
consumers, could be taken sooner with a corresponding benefit to public 
health.
    The public health benefits would be supplemented with operating 
cost reductions within FDA. Assuming the number of MDRs remains fairly 
constant over time, electronic reporting would

[[Page 42209]]

save the agency about $1.25 million annually in data entry costs, which 
is about one-half of our current data entry contract.

B. Costs

    There are about 18,000 medical device manufacturers and importers 
identified in FDA's medical device registration database and 
approximately 38,500 user facilities identified in the 2002 U.S. 
Economic Census that would be affected by the proposed rule (for a 
total of 56,500 manufacturers, importers, and user facilities) (Census, 
2002). Table 1 shows the estimated numbers of firms and establishments 
in the affected industries.

                                   Table 1.--Affected Firms and Establishments
----------------------------------------------------------------------------------------------------------------
      North American Industry                                                                      No. of
Classification System (NAICS) Code             Description                No. of Firms         Establishments
----------------------------------------------------------------------------------------------------------------
Various                             Devices                                         18,000                 8,000
----------------------------------------------------------------------------------------------------------------
622                                 Hospitals                                        3,800                 6,342
----------------------------------------------------------------------------------------------------------------
6231                                Nursing care facilities                          7,826                15,480
----------------------------------------------------------------------------------------------------------------
6214                                Outpatient care centers                         11,125                23,912
----------------------------------------------------------------------------------------------------------------
6215                                Medical and diagnostic                           5,736                 9,844
                                     laboratories
----------------------------------------------------------------------------------------------------------------
6216                                Home health care services                        9,987                15,016
----------------------------------------------------------------------------------------------------------------
Total                                                                               56,474                88,594
----------------------------------------------------------------------------------------------------------------

The incremental cost of changing to electronic submissions for each 
affected entity would vary by the size, type, and corporate structure 
of the firm, as well as by its current electronic submission 
capability. The total costs associated with this proposed rule would 
include one-time set-up costs and annual operating costs.
1. One-Time Costs
    One-time costs would be the sum of the costs of:
     Rewriting standard operating procedures (SOPs) and 
training the appropriate personnel,
     Installing and validating either the installation of 
CDRH's CeSub Web interface software or the programming and 
configuration of a computer system to transmit reports directly to the 
FDA ESG using the HL7 ICSR, and
     Acquiring the electronic digital certificate required by 
the FDA ESG.
    a. Rewriting SOPs and training personnel. All entities affected 
would need to update their SOPs to include the electronic submission 
requirement. For medical device manufacturers, importers, and 
hospitals, we estimate that it would require about 10 hours to make the 
modifications and train the appropriate people on the new procedures. 
For the other user facilities, we assume that the corporate or regional 
offices would have the major responsibility for medical device 
reporting and thus the SOPs for these individual entities would require 
less time to modify. For this analysis we estimated that 55 percent of 
the other user facilities would require about 10 hours to modify their 
SOPs and the remaining 45 percent would require about 2 hours.\1\ The 
estimated one-time incremental cost for updating SOPs, assuming an 
average wage rate of $52 per hour,\2\ (Bureau of Labor Statistics 
(BLS), 2006) is about $34.1 million [((18,000 medical device 
manufacturers and importers + 6,300 hospitals) x 10 hours) + ((0.45 x 2 
hours + 0.55 x 10 hours) x 64,500 other user facilities) x $52/hour].
---------------------------------------------------------------------------

    \1\ Percentages are based on the ratio of firms to 
establishments from 2002 Census of Manufactures data.
    \2\ $52 per hour wage is based on BLS Occupational Employment 
and Wages, May 2006, for Medical and Health Service Managers, 
Standard Occupational Classification 11-19111. Forty percent was 
added to the mean hourly wage of $37.09 to account for benefits and 
the total was rounded to the nearest whole number.
---------------------------------------------------------------------------

    b. Setting up systems for submission. MDRs would be submitted 
through the FDA ESG using one of two methods: The CDRH CeSub software 
or the HL7 ICSR. Because most entities are small and submit few if any 
MDRs annually, we assume they would probably use the CDRH CeSub 
software, which allows for the submission of one MDR at a time. To 
comply using this submission method, manufacturers, importers, and user 
facilities would need high-speed Internet connections and would have to 
download and install up to three free software programs, validate the 
installation, and train the appropriate personnel on the new 
procedures. Entities that have dedicated information technology (IT) 
staff would be able to install and validate the installation 
themselves. Smaller manufacturers, importers, and user entities would 
probably choose to hire an outside contractor for the installation and 
its validation.
    We do not have data on the amount of time required to install and 
validate the installation of the software or the percentage of entities 
that might need to contract out the installation. For this analysis, we 
assumed it would take an entity 8 to 16 hours to install and validate 
the installation of CDRH's CeSub software and install, if necessary, 
Java Runtime Edition software and Java security policy files for their 
Internet browser. This estimate also includes the time required to 
notify FDA, run a test submission through the FDA ESG, and to train the 
appropriate staff to use the new program. We are also assuming that 
almost all medical device manufacturers, importers, and all user 
facilities would use this method to submit MDRs. Using an average wage 
of $46.50 for computer and mathematical occupations\3\ (BLS 2006), we 
estimate the cost to install and use the software to be between $21.0 
million and $41.7 million [(8 hours x $46.50 wage) x (38,500 user 
facilities + 18,000 manufacturers and importers) to (16 hours x $46.50 
wage) x (38,500 user facilities + 18,000 manufacturers and importers)].
---------------------------------------------------------------------------

    \3\ BLS Occupation Employment and Wages, May 2006, by 
occupation, for all industries (http://www.bls.gov). Wage ($46.50) 
includes mean hourly wage of $33.22 for Standard Occupational 
Classification 15-0000, computer and mathematics occupations, all 
industries; we add 40 percent to account for benefits.
---------------------------------------------------------------------------

    Entities that submit a large number of MDRs each year may choose to 
use the HL7 ICSR method to submit the reports.

[[Page 42210]]

This method allows for the batch submission of multiple MDRs at faster 
transmission rates. We do not know at what threshold of reporting it 
becomes cost effective for an entity to submit medical device reports 
using this method. An analysis of FDA submission data for a 6-year 
period indicated that about 20 large medical device manufacturers 
submit 500 or more MDRs each year and about 85 submit close to 100 
medical device reports per year. We assumed that the actual number of 
entities using the HL7 ICSR would fall somewhere within this range (20 
to 85). We also assumed that only entities that have existing 
infrastructure to support HL7 ICSR transmissions would choose this 
method to submit MDRs. We estimated that it would take about 50 hours 
to set up their gateway to be compatible with the agency's system. 
Using the wage $46.50, the one-time cost for establishing HL7 ICSR 
submission capabilities would range between $50 thousand and $200 
thousand [($46.50 x 50 hours) x 20 entities) and ($46.50 x 50 hours) x 
85 entities)].
    c. Electronic certificates. All entities would need an electronic 
certificate to submit any electronic regulatory document to the FDA 
ESG. The electronic certificate identifies the sender and serves as an 
electronic signature. Entities that have not submitted any electronic 
documents to the agency would incur a one-time cost to acquire the 
certificate and recurring costs to keep the certificate active as a 
result of this proposed rule. The certificates cost about $20 and are 
valid for 1 year. We assume that the search and transactions costs 
involved in the initial acquisition of the certificate doubles the cost 
of the certificate to a total of $40 for the first year, half of which 
would be setup costs. If all entities needed to acquire electronic 
certificates, the one-time search and acquisition costs would be $1.1 
million ($20 acquisition cost x 56,500 entities).
    In addition to the costs we have estimated, manufacturers, 
importers, and user facilities affected by this proposed rule may have 
to hire outside expertise to install and validate the software 
installation to comply with the proposed requirements.
    Table 2 summarizes the estimated one-time costs by type of cost for 
this proposed rule by cost and type of manufacturers, importers, and 
user entities. The estimate of the total one-time costs for all 
manufacturers, importers, and user facilities ranges from $58.6 million 
to $79.7 million. Much of the cost involves acquiring the electronic 
certificate for the capability to submit any regulatory document to the 
FDA, including installation and validation of the CeSub software or to 
establish HL7 ICSR capabilities. Therefore, manufacturers, importers, 
and user facilities that are not already making electronic submissions 
of any kind to the agency if this proposed rule becomes final would 
incur these total costs.

                           Table 2.--Summary of One-Time Costs by Industry ($ Million)
----------------------------------------------------------------------------------------------------------------
                         Install and validate       Gateway to gateway                            Total
           Modifying        CeSub software      -------------------------- Acquiring e--------------------------
Industry      SOPs    --------------------------                           certificate
                           low          high         low          high                      low          high
----------------------------------------------------------------------------------------------------------------
Medical          9.4          6.7         13.4          0.05         0.2          0.4         16.6         23.4
 Device
----------------------------------------------------------------------------------------------------------------
User            26.9         14.3         28.6   ...........  ...........         0.8         42.0         56.3
 Facilit
 y
----------------------------------------------------------------------------------------------------------------
Total           36.3         21.0         42.0          0.05         0.2          1.2         58.6         79.7
----------------------------------------------------------------------------------------------------------------
Annualized at 3 percent over 10 years                                                          6.9          9.3
----------------------------------------------------------------------------------------------------------------
Annualized at 7 percent over 10 years                                                          8.3         11.4
----------------------------------------------------------------------------------------------------------------

2. Annual Costs
    The annual costs of this proposed rule would include the costs of:
     Maintaining certificates and
     High-speed Internet access.
    a. Maintaining electronic certificates. Manufacturers, importers, 
and user facilities would bear the cost to maintain the electronic 
certificate that identifies the sender. In addition to having to renew 
the certificate on a regular basis, those entities who have not 
submitted MDRs would also have to ensure they are capable of 
transmitting electronic MDRs to FDA should such a report submission be 
necessary. To add these costs to the cost of the certificate itself, we 
assume that entities would incur an additional annually recurring cost 
equal to one-half the price of the certificate ($10), for a total 
annually recurring cost of $30. If all manufacturers, importers, and 
user facilities need to acquire electronic certificates, the annual 
cost would be $1.7 million ($30 acquisition certificate renewal and 
acquisition cost x 56,500 entities).
    b. High-speed Internet access. Entities would also need high-speed 
Internet access to use either of the submission methods. A 2004 study 
of small businesses sponsored by the Small Business Administration 
(SBA) found that essentially all small firms had Internet access and 
about 50 percent had high-speed Internet access (Pociask, 2004). The 
average cost of high speed access was about $40 per month more than 
dial-up access. Because the average cost of Internet access has been 
going down over time, we estimate that by the time this proposed rule 
would be made final, about 75 percent of device and user facilities 
would have high speed access. The average annual recurring increase in 
cost for high speed Internet access for the remaining 25 percent of the 
entities would be $6.8 million (($40 x 12 months) x (0.25 x (18,000 
manufacturers and importers + 38,500 user facilities))).
    Table 3 shows the annual costs of the proposed rule. As with the 
one-time costs, only entities not making electronic regulatory document 
submissions of any kind to the agency if this proposed rule becomes 
final would incur all these costs. There would be no change in the 
actual time required to research and prepare the MDRs, nor would there 
be any additional reporting requirements as a result of this proposed 
rule. Manufacturers, importers, and user facilities that maintain paper 
FDA Form 3500A records for their internal MDR files own use could still 
do so under the proposed rule.

[[Page 42211]]

                            Table 3.--Summary of Annual Costs by Industry ($ million)
----------------------------------------------------------------------------------------------------------------
                                                        Acquiring
                     Industry                           electronic      High-speed Internet         Total
                                                       certificate             access
----------------------------------------------------------------------------------------------------------------
Medical Device                                                     0.5                  2.2  ...................
----------------------------------------------------------------------------------------------------------------
User Facility                                                      1.2                  4.6  ...................
----------------------------------------------------------------------------------------------------------------
Total                                                              1.7                  6.8                  8.5
----------------------------------------------------------------------------------------------------------------

    Cost savings: We estimate a modest industry savings of about $3.2 
million annually because electronic submission should reduce the time 
it takes to submit documents. It should be noted that the savings 
accumulate to firms submitting MDRs; firms that submit very few or no 
MDRs would not realize any savings.

C. Summary of Benefits and Costs

    The principal benefit of this proposed rule would be the public 
health benefits associated with more rapid processing and analysis of 
the 100,000 initial individual MDRs currently submitted to FDA on a 
paper FDA Form 3500A. In addition, requiring electronic submission of 
MDRs is expected to reduce FDA annual operating costs by $1.25 million 
and generate industry savings of about $3.2 million.
    The total one-time cost for modifying SOPs and establishing 
electronic submission capabilities is estimated to range from $58.6 
million to $79.7 million. Annually recurring costs totaled $8.5 million 
and include maintenance of electronic submission capabilities, 
including renewing the electronic certificate, and for some entities 
the incremental cost to maintain high-speed Internet access. The total 
annualized cost of the proposed rule, assuming a 7-percent discount 
rate over 10 years, would be from $16.8 million to $19.9 million ($15.4 
million to $17.8 million at a 3-percent discount rate). We request 
comment on the accuracy and completeness of the assumptions used to 
estimate the costs of this proposed rule. For example, we invite 
comment on our use of a 10-year time horizon and whether a shorter or a 
longer horizon would be more appropriate to express the social costs of 
this proposed rule.

D. Alternatives Considered

    During the development of this proposed rule, we considered a 
number of alternative approaches. The first was to allow manufacturers, 
importers, and user facilities to voluntarily submit MDRs 
electronically. Because our experience has shown that a number of 
medical device firms and user facilities would resist changing their 
procedures for a long period of time, we would not attain the benefits 
of standardized formats and quicker access to medical device adverse 
event data. The FDA, for example, would have to maintain contracts to 
handle the input of information from both written and electronic MDRs. 
A voluntary system, therefore, would fail to achieve the goals of this 
proposed rule.
    Another alternative was to allow small entities more time to comply 
with the electronic submission requirements. This alternative would 
allow small entities to delay compliance. Under this alternative, we 
would not receive the full data-entry savings from requiring electronic 
submissions or all the benefits of quicker access to these reports. 
Because so many device companies are small entities, this approach 
would significantly postpone the benefits the rule is intended to 
confer. Moreover, as shown in the following section, the estimated 
incremental costs per small entity from the proposed rule are small, so 
the cost reduction per small entity from delayed compliance would also 
be small.

E. Regulatory Flexibility Analysis

    The SBA defines a small medical device manufacturer as having fewer 
than 500 employees. Based on data from U.S. Census, about 98 percent of 
device firms affected by this proposed rule are considered small 
entities, and have an average value of shipments of about $9.0 
million.\4\ Businesses in the health care industry are classified as 
small if their revenues are below a certain level. Hospitals are small 
if their total revenue falls below $25 million and the other user 
facilities are considered small if their revenues are below $10 
million. U.S. Census data indicates that about 87 percent of the user 
facilities are classified as small and have a weighted average revenue 
of about $3.3 million.\5\ However, very few user facilities submit MDRs 
in any given year. While this proposed rule will now require those 
reports submitted to the agency to be in electronic format, the content 
of a report is not being changed from that already addressed on the 
current FDA Form 3500A. The average costs for these manufacturers, 
importers, and user facilities are listed in table 4. The average total 
annualized cost per small entity, assuming a 7-percent discount rate 
over 10 years, would range from $581 to $693; at a 3-percent discount 
rate, average annualized costs would range from $568 to $661. These 
costs represent less than 0.1 percent of revenues for medical device 
firms and less than 0.1 percent of revenues for user facilities.
---------------------------------------------------------------------------

    \4\ U.S. Census Bureau, 2002 Economic Census, Manufacturing 
Industry Series, Industry Statistics by Employment Size for NAICS 
codes: 334510, 339112, 339113, 339114, and 339115 (www.census.gov).
    \5\ U.S. Census Bureau, 2002 Economic Census, Release Date 11/
22/2005, Sector 62: Health Care and Social Assistance: Subject 
Series--Establishment and Firm Size: Receipts/Revenue Size the 
United States for NAICS 622, 6231, 6214, 6215, and 6216 accessed via 
American Fact Finder (www.census.gov).
---------------------------------------------------------------------------

    We considered two possible alternatives for regulatory relief for 
small businesses. As described above, one regulatory alternative would 
be longer compliance times for small entities. We would not receive the 
full data-entry savings from requiring electronic submissions or all 
the benefits of quicker access to these reports. Because so many device 
companies are small entities, this approach would significantly 
postpone the benefits the rule is intended to confer. Moreover, as 
shown above, the estimated incremental costs per small entity from the 
proposed rule are small, so the cost reduction per small entity from 
delayed compliance would also be small.
    In addition, we considered proposing a waiver to the electronic 
submission requirement for small firms that can demonstrate an economic 
hardship. Because the estimated incremental costs per small entity from 
the proposed rule are small, the cost reduction per small entity from a 
waiver would also be small.
    We ask for comments on both of these options for regulatory relief 
for small entities.
    While the estimated costs per affected entity are low, FDA does not 
have adequate information on the electronic capabilities of all of the 
firms affected

[[Page 42212]]

by this proposed rule and has made many assumptions to derive these 
estimate used in this analysis, therefore we do not propose to certify 
that this proposed rule would not have a significant economic impact on 
a substantial number of small entities. FDA requests comment on this 
issue.

                             Table 4.--Incremental Compliance Costs per Small Entity
----------------------------------------------------------------------------------------------------------------
                                          One-Time  Costs                                Total  Annualized
                                 --------------------------------    Annually    -------------------------------
                                        low            high          Recurring          low            high
----------------------------------------------------------------------------------------------------------------
Rewriting SOPs                               104             520  ..............  ..............  ..............
----------------------------------------------------------------------------------------------------------------
Software Installation and                    372             744  ..............
 validation of installation
----------------------------------------------------------------------------------------------------------------
Acquiring Electronic Certificate                40                ..............
----------------------------------------------------------------------------------------------------------------
Maintaining submission                                                        30
 capabilities
----------------------------------------------------------------------------------------------------------------
Upgrade Internet Access                                                      480  ..............  ..............
----------------------------------------------------------------------------------------------------------------
7 percent discount rate                                           ..............             581             693
----------------------------------------------------------------------------------------------------------------
3 percent discount rate                                           ..............             568             661
----------------------------------------------------------------------------------------------------------------

VI. Paperwork Reduction Act of 1995

    This proposed rule contains information collection provisions that 
are subject to review by OMB under the PRA (44 U.S.C. 3501-3520). A 
description of these provisions is given in this document 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 these topics: (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.
    Title: Medical Device Reporting
    Description: In accordance with the proposed Medical Device 
Reporting regulation, medical device manufacturers, importers, and user 
facilities would be required to submit MDRs to FDA, to maintain 
records, and may also seek exemption or variance from these 
requirements. FDA is also proposing to amend Sec. Sec.  803.32, 803.42, 
and 803.52 to make minor wording changes and corrections to these 
sections to reflect modifications already made to FDA Form 3500A and 
its instructions. Manufacturers, importer, and user facilities are 
currently submitting paper MDR reports on FDA Form 3500A. The existing 
information collection for part 803 is approved under OMB control 
number 0910-0437. The changes to the burden associated with this 
proposed rule are described below and have been sent to OMB as a 
revision to OMB control number 0910-0437 for review under section 
307(d) of the PRA.
    Section 519(a)(1) of the act (21 U.S.C. 360i(a)(1)) requires every 
manufacturer or importer to report ``whenever the manufacturer or 
importer receives or otherwise becomes aware of information that 
reasonably suggests that one of its marketed devices--
    (A) may have caused or contributed to a death or serious injury, or
    (B) has malfunctioned and that such device or a similar device 
marketed by the manufacturer or importer would be likely to cause or 
contribute to a death or serious injury if the malfunction were to 
recur * * *''
    Section 519(b)(1)(A) of the act requires ``whenever a device user 
facility receives or otherwise becomes aware of information that 
reasonably suggests that a device has or may have caused or contributed 
to the death of a patient of the facility, the facility shall, as soon 
as practicable but not later than 10 working days after becoming aware 
of the information, report the information to the Secretary and, if the 
identity of the manufacturer is known, to the manufacturer of the 
device.''
    Section 519(b)(1)(B) of the act requires ``whenever a device user 
facility receives or otherwise becomes aware of: (i) information that 
reasonably suggests that a device has or may have caused or contributed 
to the serious illness of, or serious injury to, a patient of the 
facility * * *, shall, as soon as practicable but not later than 10 
working days after becoming aware of the information, report the 
information to the manufacturer of the device or to the Secretary if 
the identity of the manufacturer is not known.''
    Complete, accurate, and timely adverse event information is 
necessary for the identification of emerging device problems so the 
agency can protect the public health under section 519 of the act. FDA 
is requesting approval for the information collection requirements 
contained in part 803.
    Description of Respondents: Manufacturers and importers of medical 
devices and device user facilities. Device user facility means a 
hospital, ambulatory surgical facility, nursing home, outpatient 
diagnostic facility, or outpatient treatment facility as defined in 
Sec.  803.3, which is not a physician's office (also defined in Sec.  
803.3).
    The total annual estimated burden imposed by this collection of 
information is 21,525 hours annually.

[[Page 42213]]

                                                       Table 5.--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 No. of        Annual Frequency     Total Annual        Hours per
       21 CFR  Section                FDA  Form No.           Respondents        Per Response        Responses           Response         Total  Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.19                         ..........................                 55                  4                220                  1                220
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.30 and 809.32              ..........................                411                  2                822               0.33                271
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.33                         3419                                      411                  1                411                  1                411
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.40 and 803.42              ..........................                 44                 20                880               0.33                290
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.50 and 803.52              ..........................              1,304                 58             75,632               0.11              8,248
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.56                         ..........................              1,200                 48             57,600               0.10              5,760
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                             15,200
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                 Table 6.--Estimated Annual Recordkeeping Burden
----------------------------------------------------------------------------------------------------------------
                         No. of         Frequency per       Total Annual
 21 CFR  Section      Respondents       Recordkeeping         Records       Hours per  Record     Total Hours
----------------------------------------------------------------------------------------------------------------
803.17                         1,677                  1              1,677                3.3              5,534
----------------------------------------------------------------------------------------------------------------
803.18 (a) to (d)                527                  1                527                1.5                791
----------------------------------------------------------------------------------------------------------------
Total                          2,204  .................              2,204  .................              6,325
----------------------------------------------------------------------------------------------------------------

    The approved MDR reporting and recordkeeping burden for paper 
submissions is 138,271 hours. This proposed rule reporting and 
recordkeeping burden for electronic submissions is 21,525 hours, a 
decrease of 123,071 hours. Based on an average wage rate of $46.50 per 
hour, the total cost to respondents associated with these reporting and 
recordkeeping burdens is $1,000,913. An explanation for the burden 
decrease is provided below.

A. Reporting Requirements

    The number of respondents for each Code of Federal Regulations 
(CFR) section in table 5 is based upon the number of respondents 
entered into FDA's internal databases. FDA estimates that electronic 
submission will decrease the burden associated with Sec. Sec.  803.19, 
803.30, 803.32, 803.40, 803.50, 803.52, and 803.56. We believe 
electronic submission will neither increase nor decrease burden 
associated with Sec.  803.33, which we estimate will take 1 hour. We 
believe Sec.  803.19 will take 1 hour, while Sec. Sec.  803.30, 803.32, 
803.40, and 803.42 will take 20 minutes. Sections 803.50 and 803.52 
will take 7 minutes. Section 803.56 will take 6 minutes. The following 
table summarizes our burden estimates and how we believe they will 
change due to electronic submission.

                               Table 7.--Estimated Reporting Burden Program Change
----------------------------------------------------------------------------------------------------------------
                                                                    Hours per response
                                              Hours per response       as result of
               21 CFR Section                 under current paper       electronic            Burden Change
                                              submission process        submission
----------------------------------------------------------------------------------------------------------------
803.19                                                          3                  1         Reduction (2 hours)
----------------------------------------------------------------------------------------------------------------
803.30 and 809.32                                               1                  0.33    Reduction (.66 hours)
----------------------------------------------------------------------------------------------------------------
803.33                                                          1                  1                   no change
----------------------------------------------------------------------------------------------------------------
803.40 and 803.42                                               1                  0.33    Reduction (.66 hours)
----------------------------------------------------------------------------------------------------------------
803.50 and 803.52                                               1                  0.11    Reduction (.89 hours)
----------------------------------------------------------------------------------------------------------------
803.56                                                          1                  0.10    Reduction (.90 hours)
----------------------------------------------------------------------------------------------------------------

    As previously described, there are two reporting options. The first 
one is CeSub for low volume reporters and the second one is HL7 ICSR 
for high volume reporters. We are basing our hours per response for 
both systems on FDA's experience using the two options.

B. Recordkeeping Requirements

    The number of respondents for each CFR section in table 6 is based 
upon the number of respondents entered into FDA's internal databases. 
The agency believes that the majority of manufacturers, user 
facilities, and importers have already established written procedures 
to document complaints and information to meet the MDR requirements as 
part of their internal quality control system. The following table 
summarizes our burden estimates and how we believe they will change due 
to electronic submission.

[[Page 42214]]

                             Table 8.--Estimated Recordkeeping Burden Program Change
----------------------------------------------------------------------------------------------------------------
                                                                       Hours per response
                                                 Hours per response       as result of
                21 CFR Section                   under current paper       electronic           Burden Change
                                                 submission process        submission
----------------------------------------------------------------------------------------------------------------
803.17                                                          10                     3.3        Reduction (7.7
                                                                                                          hours)
----------------------------------------------------------------------------------------------------------------
803.18 (a) to (d)                                                1.5                   1.5             No change
----------------------------------------------------------------------------------------------------------------

C. Total Annual Cost Burden

    As stated earlier, the cost to respondents for these reporting and 
recordkeeping requirements is $1,000,913. In addition, the conversion 
from paper to electronic submissions will result in capital costs, both 
one-time costs as well as annual costs, as discussed earlier in this 
proposed rule in the economic analysis. One-time capital costs include 
the cost to modify reporting systems, installing and validating CeSub 
software, installing gateway to gateway submission capabilities, and 
acquiring e-certificates and have been estimated to range from a low of 
$58.6 million to a high of $79.7 million. Once the procedures have been 
modified, there is an operating and maintenance cost to renew the 
digital certificate and maintain high-speed internet access, which have 
been estimated cost $8.5 million each year. Burden estimates are based 
on reports processed between July 1, 2005, and June 30, 2006, with the 
existing medical device adverse event reporting program.
    In compliance with the PRA, the agency has submitted the 
information collection provisions of this proposed rule to OMB for 
review. Interested persons are requested to send comments regarding 
information collection to OMB (see the DATES and ADDRESSES sections of 
this document).

VII. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
this rule does not contain policies that have federalism implications 
as defined in the order and, consequently, a federalism summary impact 
statement is not required.

VIII. 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.

IX. 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 is not responsible for 
any subsequent changes to the Web site after this document publishes in 
the Federal Register.)
    1. U.S. Census Bureau, 2002 Economic Census Industry Series: 
NAICS Code 62, Health Care and Social Assistance (http://
www.census.gov). Total is the sum of firms in NAICS 622, 6231, 6214, 
6215, and 6216.
    2. BLS Occupational Employment and Wages May 2005 for Medical 
and Health Service Managers, Standard Occupational Classification, 
11-19111.
    3. Pociask, Steven, A Survey of Small Businesses' 
Telecommunications Use and Spending, SBA Office of Advocacy contract 
number SBA-HQ-02-M-0493, March 2004.

List of Subjects in 21 CFR Part 803

    Imports, Medical devices, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, FDA proposes 
to amend part 803 to read as follows:

PART 803--MEDICAL DEVICE REPORTING

    1. The authority citation for 21 CFR part 803 continues to read as 
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

Sec.  803.3  [Amended]

    2. Amend Sec.  803.3 by removing the definition for ``Five-day 
report''.

Sec.  803.11  [Removed]

    3. Remove Sec.  803.11.
    4. Revise Sec.  803.12 to read as follows:

Sec.  803.12  How do I submit reports and supplements?

    (a) Manufacturers, user facilities, and importers must submit 
initial and supplemental reports to FDA in an electronic format that 
FDA can process, review, and archive. FDA will provide and update 
information on how to provide the electronic submission (e.g., 
preparation and organization of files, file formats, media and method 
of transmission).
    (b) If you are confronted with a public health emergency, this can 
be brought to FDA's attention by contacting the FDA Office of Emergency 
Operations (HFA-615), Office of Crisis Management, Office of the 
Commissioner, at 301-443-1240, followed by the submission of an e-mail 
to emergency.operations@fda.hhs.gov. Note: This action does not satisfy 
your obligation to report under part 803.
    (c) You may submit a voluntary telephone report to the MEDWATCH 
office at 800-FDA-1088. You may also obtain information regarding 
voluntary reporting from the MEDWATCH office at 800-FDA-1088. You may 
also find the voluntary MEDWATCH 3500 form and instructions to complete 
it at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/
default.htm.
    5. Revise Sec.  803.13 to read as follows:

Sec.  803.13  Do I need to submit reports in English?

    Yes. You must submit all reports required by this part in English.

Sec.  803.14  [Removed]

    6. Remove Sec.  803.14.
    7. Amend Sec.  803.18 by revising paragraph (b)(1)(ii) and adding 
paragraph (b)(1)(iii) to read as follows:

Sec.  803.18  What are the requirements for establishing and 
maintaining MDR files or records that apply to me?

* * * * *
    (b)(1) * * *
    (ii) Copies of all reports submitted under this part (whether paper 
or electronic), and of all other information related to the event that 
you submitted to us or other entities such as an importer, distributor, 
or manufacturer.
    (iii) Copies of all electronic acknowledgments FDA sends you in 
response to your electronic submissions.
* * * * *
    8. Amend Sec.  803.19 by revising paragraphs (b) and (e) to read as 
follows:

[[Page 42215]]

Sec.  803.19  Are there exemptions, variances, or alternative forms of 
adverse event reporting requirements?

* * * * *
    (b) If you are a manufacturer, importer, or user facility, you may 
request an exemption or variance from any or all of the reporting 
requirements in this part, including the requirements of Sec.  
803.12(a). You must submit the request to us in writing at the 
following address: MDR Exemption Requests, Office of Surveillance and 
Biometrics (HFZ-530), 1350 Piccard Dr., Rockville, MD 20850. Your 
request must include information necessary to identify you and the 
device; a complete statement of the request for exemption, variance, or 
alternative reporting; and an explanation why your request is 
justified. If you are requesting a variance to the requirement to 
submit reports to FDA in electronic format, under Sec.  803.12(a), your 
request should indicate for how long you would require this variance.
* * * * *
    (e) If we grant your request for a reporting modification, you must 
submit any reports or information required in our approval of the 
modification. The conditions of the approval will replace and supersede 
the regular reporting requirement specified in this part until such 
time that we revoke or modify the alternative reporting requirements in 
accordance with paragraph (d) of this section, or until the date 
specified in our response granting your variance, at which time, the 
provisions of this part will again apply.
    9. In Sec.  803.20, revise paragraph (a), redesignate paragraphs 
(b) and (c) as paragraphs (c) and (d), and add new paragraph (b) to 
read as follows:

Sec.  803.20  How do I complete and submit an individual adverse event 
report?

    (a) If you are a health professional or consumer, you may submit 
voluntary reports to FDA regarding devices or other FDA-regulated 
products using the FDA Form 3500.
    (b) A mandatory electronic submission from a user facility, 
importer, or manufacturer, must contain the information from the 
applicable blocks of FDA Form 3500A. All electronic submissions must 
include information about the patient, the event, the device, and the 
``initial reporter.'' An electronic submission from a user facility or 
importer must include the information from block F. An electronic 
submission from a manufacturer must include the information from blocks 
G and H. If you are a manufacturer and you receive a report from a user 
facility or importer, you must incorporate that information in your 
electronic submission and include any corrected or missing information.
* * * * *
    10. Add Sec.  803.23 to read as follows:

Sec.  803.23  Where can I find information on how to prepare and submit 
an MDR in electronic format?

    (a) You may obtain information on how to prepare and submit reports 
in an electronic format that FDA can process, review, and archive at 
http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm.
    (b) We may sometimes update information on how to prepare and 
submit reports electronically. If we do make modifications, we will 
ensure that we alert reporters by updating the eMDR Web page.
    11. Amend Sec.  803.30 by revising paragraphs (a)(1) and (a)(2) to 
read as follows:

Sec.  803.30  If I am a user facility, what reporting requirements 
apply to me?

    (a) * * *
    (1) Reports of death. You must submit a report to us as soon as 
practicable but no more than 10 work days after the day that you become 
aware of information, from any source, that reasonably suggests that a 
device has or may have caused or contributed to the death of a patient 
of your facility. You must also submit the report to the device 
manufacturer, if known. You must submit the information required by 
Sec.  803.32. Reports sent to the agency must be submitted in 
accordance with the requirements of Sec.  803.12(a).
    (2) Reports of serious injury. You must submit a report to the 
manufacturer of the device no later than 10 work days after the day 
that you become aware of information, from any source, that reasonably 
suggests that a device has or may have caused or contributed to a 
serious injury to a patient of your facility. If the manufacturer is 
not known, you must submit the report to us. You must report 
information required by Sec.  803.32. Reports sent to the agency must 
be submitted in accordance with the requirements of Sec.  803.12(a).
* * * * *
    12. Amend Sec.  803.32 by revising paragraphs (b)(4) and (c) to 
read as follows:

Sec.  803.32  If I am a user facility, what information must I submit 
in my individual adverse event reports?

* * * * *
    (b) * * *
    (4) Date of this report;
* * * * *
    (c) Device information (Form 3500A, Block D). You must submit the 
following:
    (1) Brand name;
    (2) Product Code, if known, and Common Device Name;
    (3) Manufacturer name, city, and state;
    (4) Model number, catalog number, serial number, lot number, or 
other identifying number, and expiration date;
    (5) Operator of the device (health professional, lay user/ patient, 
other);
    (6) Date of device implantation (month, day, year), if applicable;
    (7) Date of device explantation (month, day, year), if applicable;
    (8) Whether the device is a single-use device that was reprocessed 
and reused on a patient (Yes, No)?
    (9) If the device is a single-use device that was reprocessed and 
reused on a patient (yes to paragraph (c)(8) of this section), the name 
and address of the reprocessor;
    (10) Whether the device was available for evaluation and whether 
the device was returned to the manufacturer; if so, the date it was 
returned to the manufacturer; and
    (11) Concomitant medical products and therapy dates. (Do not report 
products that were used to treat the event.)
* * * * *
    13. Revise Sec.  803.33 to read as follows:

Sec.  803.33  If I am a user facility, what must I include when I 
submit an annual report?

    (a) You must submit to us an annual report on FDA Form 3419. You 
must submit an annual report by January 1, of each year. You may obtain 
this form from any of the following:
    (1) The Consolidated Forms and Publications Office, Beltsville 
Service Center, 6351 Ammendale Rd., Landover, MD 20705;
    (2) FDA, MEDWATCH (HF-2), 5600 Fishers Lane, Rockville, MD 20857, 
301-827-7240;
    (3) Division of Small Manufacturers, International, and Consumer 
Assistance, Office of Communication, Education, and Radiation Programs, 
Center for Devices and Radiological Health (CDRH) (HFZ-220), 1350 
Piccard Dr., Rockville, MD 20850, by e-mail: DSMICA@CDRH.FDA.GOV, or 
FAX: 301-443-8818; or
    (4) On the Internet at http://www.fda.gov/Safety/MedWatch/
HowToReport/DownloadForms/default.htm.
    (b) You must clearly identify your annual report as such. You must 
submit your annual report to FDA, CDRH, Medical Device Reporting, P.O. 
Box 3002, Rockville, MD 20847-3002. Your annual report must include:

[[Page 42216]]

    (1) Your CMS provider number used for medical device reports, or 
the number assigned by us for reporting purposes in accordance with 
Sec.  803.3;
    (2) Reporting year;
    (3) Your name and complete address;
    (4) Total number of reports attached or summarized;
    (5) Date of the annual report and report numbers identifying the 
range of medical device reports that you submitted during the report 
period (e.g., 1234567890-2007-0001 through 1000);
    (6) Name, position title, and complete address of the individual 
designated as your contact person responsible for reporting to us and 
whether that person is a new contact for you; and
    (7) Information for each reportable event that occurred during the 
annual reporting period including:
    (i) Report number;
    (ii) Name and address of the device manufacturer;
    (iii) Device brand name and common name;
    (iv) Product model, catalog, serial and lot number;
    (v) A brief description of the event reported to the manufacturer 
and/or us; and
    (vi) Where the report was submitted, i.e., to the manufacturer, 
importer, or us.
    (c) In lieu of submitting the information in paragraph (b)(7) of 
this section, you may submit a copy of each medical device report that 
you submitted to the manufacturers and/or to us during the reporting 
period.
    (d) If you did not submit any medical device reports to 
manufacturers or us during the time period, you do not need to submit 
an annual report.
    14. Revise Sec.  803.40 to read as follows:

Sec.  803.40  If I am an importer, what reporting requirements apply to 
me?

    (a) Reports of deaths or serious injuries. You must submit a report 
to us, and a copy of this report to the manufacturer, as soon as 
practicable, but no later than 30 calendar days after the day that you 
receive or otherwise become aware of information from any source, 
including user facilities, individuals, or medical or scientific 
literature, whether published or unpublished, that reasonably suggests 
that one of your marketed devices may have caused or contributed to a 
death or serious injury. You must submit the information required by 
Sec.  803.42. Reports must be submitted in accordance with the 
requirements of Sec.  803.12(a).
    (b) Reports of malfunctions. You must submit a report to the 
manufacturer as soon as practicable but no later than 30 calendar days 
after the day that you receive or otherwise become aware of information 
from any source, including user facilities, individuals, or through 
your own research, testing, evaluation, servicing, or maintenance of 
one of your devices, that reasonably suggests that one of your devices 
has malfunctioned and that this device or a similar device that you 
market would be likely to cause or contribute to a death or serious 
injury if the malfunction were to recur. You must submit the 
information required by Sec.  803.42.
    15. Amend Sec.  803.42 by revising paragraphs (b)(4) and (c) to 
read as follows:

Sec.  803.42  If I am an importer, what information must I submit in my 
individual adverse event reports?

* * * * *
    (b) * * *
    (4) Date of this report;
* * * * *
    (c) Device information (Form 3500A, Block D). You must submit the 
following:
    (1) Brand name;
    (2) Product Code, if known, and Common Device Name;
    (3) Manufacturer name, city, and state;
    (4) Model number, catalog number, serial number, lot number, or 
other identifying number, and expiration date;
    (5) Operator of the device (health professional, lay user/patient, 
other);
    (6) Date of device implantation (month, day, year), if applicable;
    (7) Date of device explantation (month, day, year), if applicable;
    (8) Whether the device is a single-use device that was reprocessed 
and reused on a patient (Yes, No)?
    (9) If the device is a single-use device that was reprocessed and 
reused on a patient (yes to paragraph (c)(8) of this section), the name 
and address of the reprocessor;
    (10) Whether the device was available for evaluation and whether 
the device was returned to the manufacturer; if so, the date it was 
returned to the manufacturer; and
    (11) Concomitant medical products and therapy dates. (Do not report 
products that were used to treat the event.)
* * * * *
    16. Amend Sec.  803.50 by revising paragraph (a) introductory text 
and paragraph (b)(3) to read as follows:

Sec.  803.50  If I am a manufacturer, what reporting requirements apply 
to me?

    (a) If you are a manufacturer, you must report to us the 
information required by Sec.  803.52 in accordance with the 
requirements of Sec.  803.12(a), no later than 30 calendar days after 
the day that you receive or otherwise become aware of information, from 
any source, that reasonably suggests that a device that you market:
* * * * *
    (b) * * *
    (3) You are also responsible for conducting an investigation of 
each event and evaluating the cause of the event. If you cannot submit 
complete information on a report, you must provide a statement 
explaining why this information was incomplete and the steps you took 
to obtain the information. If you later obtain any required information 
that was not available at the time you filed your initial report, you 
must submit this information in a supplemental report under Sec.  
803.56 in accordance with the requirements of Sec.  803.12(a).
    17. Amend Sec.  803.52 by revising paragraphs (b)(4), (c), and (e) 
to read as follows:

Sec.  803.52  If I am a manufacturer, what information must I submit in 
my individual adverse event reports?

* * * * *
    (b) * * *
    (4) Date of this report;
* * * * *
    (c) Device information (Form 3500A, Block D). You must submit the 
following:
    (1) Brand name;
    (2) Product code, if known, and Common Device Name;
    (3) Manufacturer name, city, and state;
    (4) Model number, catalog number, serial number, lot number, or 
other identifying number, and expiration date;
    (5) Operator of the device (health professional, lay user/patient, 
other);
    (6) Date of device implantation (month, day, year), if applicable;
    (7) Date of device explantation (month, day, year), if applicable;
    (8) Whether the device is a single-use device that was reprocessed 
and reused on a patient (Yes, No)?
    (9) If the device is a single-use device that was reprocessed and 
reused on a patient (yes to paragraph (c)(8) of this section), the name 
and address of the reprocessor;
    (10) Whether the device was available for evaluation and whether 
the device was returned to the manufacturer; if so, the date it was 
returned to the manufacturer; and
    (11) Concomitant medical products and therapy dates. (Do not report 
products that were used to treat the event.)
* * * * *

[[Page 42217]]

    (e) Reporting information for all manufacturers (Form 3500A, Block 
G). You must submit the following:
    (1) Your reporting office's contact name and address and device 
manufacturing site;
    (2) The contact's telephone number;
    (3) Your report sources;
    (4) Date received by you (month, day, year);
    (5) PMA/510k Number and whether or not the product is a combination 
product;
    (6) Type of report being submitted (e.g., 5-day, initial, 
followup); and
    (7) Your report number.
* * * * *
    18. Revise the introductory text of Sec.  803.53 to read as 
follows:

Sec.  803.53  If I am a manufacturer, in which circumstances must I 
submit a 5-day report?

    You must submit a 5-day report to us with the information required 
by Sec.  803.52 in accordance with the requirements of Sec.  803.12(a) 
no later than 5 work days after the day that you become aware that:
* * * * *
    19. Amend Sec.  803.56 by revising the introductory text and 
paragraphs (a) and (c) to read as follows:

Sec.  803.56  If I am a manufacturer, in what circumstances must I 
submit a supplemental or followup report and what are the requirements 
for such reports?

    If you are a manufacturer, when you obtain information required 
under this part that you did not provide because it was not known or 
was not available when you submitted the initial report, you must 
submit the supplemental information to us within 30 calendar days of 
the day that you receive this information. You must submit the 
supplemental or followup report in accordance with the requirements of 
Sec.  803.12(a). On a supplemental or followup report, you must:
    (a) Indicate that the report being submitted is a supplemental or 
followup report;
* * * * *
    (c) Include only the new, changed, or corrected information.

    Dated: August 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19683 Filed 8-20-09; 8:45 am]

BILLING CODE 4160-01-S