[Federal Register Volume 79, Number 89 (Thursday, May 8, 2014)]
[Pages 26434-26435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-10579]



Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Custom Device 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by June 9, 

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Custom Device Exemption''. Also include the FDA docket number 
found in brackets in the heading of this document.

Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Custom Device Exemption--(OMB Control Number 0910-NEW)

I. Background

    The custom device exemption is set forth at section 520(b)(2)(B) of 
the Federal Food, Drug, and Cosmetic Act (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 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 requesting comments in 
the Federal Register (77 FR 69488), requesting that stakeholders 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 

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

[[Page 26435]]

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.html. Guidance documents are also available 
at http://www.regulations.gov. To receive ``Custom Device Exemption,'' 
you may either send an email request to [email protected] 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.
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, to explain 
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, to describe what information FDA proposes that should be submitted 
in a custom device annual report, and to provide recommendations on how 
to submit an annual report 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.
    In the Federal Register of January 14, 2014 (79 FR 2446), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 

                                                      Table 1--Estimated Annual Reporting Burden 1
                                                                                         Number of                       Average burden
              Guidance Title: Custom Device Exemption                   Number of      responses per     Total annual     per response     Total hours
                                                                       respondents       respondent       responses        (in hours)
Section VI. Annual Reporting.......................................              33                1               33               40            1,320
\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 manufacturers 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 
manufacturers 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 displays 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 part 814, subparts B 
and E, have been approved under OMB control number 0910-0231; the 
collections of information in 21 CFR part 812 have been approved under 
OMB control number 0910-0078; and the collections of information in 21 
CFR part 807, subpart E, have been approved under OMB control number 

    Dated: May 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-10579 Filed 5-7-14; 8:45 am]