Document ID: FDA-2013-D-1601-0001
Agency: fda
Document Type: Notice
Title: Custom Device Exemption; Draft Guidance for Industry and Food and
Drug Administration Staff; Availability
Posted Date: 2014-01-14T05:00Z

[Federal Register Volume 79, Number 9 (Tuesday, January 14, 2014)]
[Notices]
[Pages 2446-2448]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00528]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1601]

Custom Device Exemption; Draft Guidance for Industry and Food and 
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Custom Device 
Exemption.'' FDA has developed a draft guidance to provide guidance to 
industry and FDA staff about implementation of the custom device 
exemption contained in the Food, Drug, and Cosmetic Act (the FD&C Act). 
The intent of this guidance is to provide draft definitions of terms 
used in the custom device exemption, explain how to interpret the 
``five units per year of a particular device type'' language contained 
in the FD&C Act, describe what information FDA proposes manufacturers 
should submit in the custom device annual report, and provide 
recommendations on how to submit an annual report for devices 
distributed under the custom device exemption. This draft guidance is 
not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 17, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Custom Device Exemption'' to the Division 
of Small Manufacturers, International, and Consumer Assistance, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-847-

[[Page 2447]]

8149. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Erin Keith, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1404, Silver Spring, MD 20993-0002, 301-796-6384, 
CustomDevices@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    The custom device exemption is set forth at section 520(b)(2)(B) of 
the FD&C Act (21 U.S.C. 360j(b)(2)(B)). A custom device is in a narrow 
category of device that, by virtue of the rarity of the patient's 
medical condition or physician's special need the device is designed to 
treat, it would be impractical for the device to comply with premarket 
review regulations and performance standards.
    Effective on July 9, 2012, the Food and Drug Administration Safety 
and Innovation Act (FDASIA) implemented changes to the custom device 
exemption contained in section 520(b) of the FD&C Act. The new 
provision amended the existing custom device exemption and introduced 
new concepts and procedures for custom devices, such as:
     Devices created or modified in order to comply with the 
order of an individual physician or dentist;
     the potential for multiple units of a device type (limited 
to no more than five units per year) qualifying for the custom device 
exemption; and
     annual reporting requirements by the manufacturer to FDA 
about devices manufactured and distributed under section 520(b) of the 
FD&C Act.
    Under FDASIA, ``devices'' that qualify for the custom device 
exemption contained in section 520(b) of the FD&C Act were clarified to 
include no more than ``five units per year of a particular device 
type'' that otherwise meet all the requirements necessary to qualify 
for the custom device exemption.
    The guidance also provides draft definitions of terms used in the 
custom device exemption, explains how FDA plans to interpret the 
concept of ``five units per year of a particular device type'' in 
section 520(b)(2)(B) of the FD&C Act, describes what information 
manufacturers should submit in a custom device annual report (annual 
report) to FDA, and provides guidance on how to submit an annual report 
for devices distributed under the custom device exemption.
    On November 19, 2012, FDA published a Notice of Request for 
Comments in the Federal Register (77 FR 69488), requesting stakeholders 
to submit information on and examples of appropriate use of the custom 
device exemption for assistance in drafting this guidance based on 
specific questions asked in the Notice. FDA has reviewed all the 
comments from the Notice and has taken them into consideration for this 
draft guidance.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on the custom 
device exemption. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do 
so by using the Internet. A search capability for all Center for 
Devices and Radiological Health guidance documents is available at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at 
http://www.regulations.gov. To receive ``Custom Device Exemption,'' you 
may either send an email request to dsmica@fda.hhs.gov to receive an 
electronic copy of the document or send a fax request to 301-847-8149 
to receive a hard copy. Please use the document number 1820 to identify 
the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal Agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of Information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following 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.

Draft Guidance for Custom Device Exemption

    This guidance is intended to assist industry by providing draft 
definitions of terms used in the custom device exemption, explains how 
FDA proposes to interpret the ``five units per year of a particular 
device type'' language contained in section 520(b)(2)(B) of the FD&C 
Act, describes what information FDA proposes should be submitted in a 
custom device annual report, and provides recommendations on how to 
submit an annual report in preparing for annual reports for devices 
distributed under the custom device exemption. In addition, 
manufacturers of custom devices are required to sign and submit a 
Custom Devices Annual Report Truthful and Accurate certificate with 
their annual report.
    Description of Respondents: The respondents of this collection of 
information are manufacturers of medical devices deemed to be custom 
devices subject to FDA's laws and regulations. The Agency estimates the 
burden of this collection of information as follows:

[[Page 2448]]

                                                      Table 1--Estimated Annual Reporting Burden 1
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                                                                                         Number of                       Average burden
              Guidance title: Custom device exemption                   Number of      responses per     Total annual     per response     Total hours
                                                                       respondents       respondent       responses        (in hours)
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Section VI. Annual Reporting.......................................              33                1               33               40            1,320
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1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates it will receive 33 reports for custom devices 
annually. The Agency reached this estimate by the number of pre-FDASIA 
manufacturers who qualified for custom devices and that percentage of 
current manufactures that qualify under post-FDASIA requirements. Only 
10 percent of manufacturers would meet this qualification, which was 
calculated by adding the number of estimated old custom device 
manufactures with the estimated new manufacturers submitting annual 
reports of custom devices each year. FDA estimates it will take custom 
device manufacturers approximately 40 hours to complete the annual 
report described in section VI of the draft guidance. FDA reached this 
time estimate based on its expectation of the amount of information 
that should be included in the report.
    Before the proposed information collection provisions contained in 
this draft guidance become effective, FDA will publish a notice in the 
Federal Register announcing OMB's decision to approve, modify, or 
disapprove the information collection provisions. An Agency may not 
conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it display a currently valid OMB 
control number.
    This draft guidance also refers to previously approved collections 
of information found in FDA regulations. These collections of 
information are subject to review by OMB under the PRA (44 U.S.C. 3501-
3520). The collections of information in 21 CFR 814, subparts B and E 
have been approved under OMB control number 0910-0231; the collections 
of information in 21 part 812 have been approved under OMB control 
number 0910-0078; and the collections of information in 21 part 807, 
subpart E have been approved under OMB control number 0910-0120.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: January 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00528 Filed 1-13-14; 8:45 am]
BILLING CODE 4160-01-P