Document ID: FDA-2013-D-1601-0016
Agency: fda
Document Type: Notice
Title: Custom Device Exemption; Guidance for Industry and Food and Drug
Administration Staff; Availability
Posted Date: 2014-09-24T04:00Z

[Federal Register Volume 79, Number 185 (Wednesday, September 24, 2014)]
[Notices]
[Pages 57112-57113]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22683]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Custom Device Exemption; 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 guidance entitled ``Custom Device Exemption.'' FDA 
has developed this document 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 define 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 information 
that 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.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Custom Device Exemption'' to the Office of the Center Director, 
Guidance and Policy Development, 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.
    Submit electronic comments on the 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: Division of Premarket and Labeling 
Compliance, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD 
20993-0002, 301-796-5770, CustomDevices@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    The custom device exemption is set forth at section 520(b) of the 
FD&C Act (21 U.S.C. 360j(b)). A custom device is in a narrow category 
of devices for which, because of the rarity of a patient's medical 
condition or a physician's special need, compliance

[[Page 57113]]

with premarket review regulations and performance standards under 
sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e) would be 
impractical.
    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 applicable to custom devices, addressing, 
among other things:
     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 not to 
exceed 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 
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. In this guidance, 
FDA interprets the five units in terms of five new custom devices per 
year (i.e., five new patients for the patient-focused custom device or 
five new physicians for the physician-focused custom device, assuming 
all other required elements for the custom device exemption are 
satisfied). The five-unit limitation includes all devices provided by a 
manufacturer to, and remaining in the possession of, the ordering 
physician and/or patient.
    The guidance defines terms used in the custom device exemption, 
explains how FDA plans to interpret the term ``five units per year of a 
particular device type'' set forth in section 520(b)(2)(B) of the FD&C 
Act, describes what information manufacturers should submit in a custom 
device annual report to FDA, and provides guidance on how to submit an 
annual report for devices distributed under the custom device 
exemption.
    On January 14, 2014, FDA issued the draft guidance entitled 
``Custom Device Exemption'' (Ref. 1). The Agency has reviewed the 
comments submitted for the draft guidance and has incorporated many of 
the recommendations in this final guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on custom devices. 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 send an email request to CDRH-Guidance@fda.hhs.gov to receive an 
electronic copy of the document. 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. 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; the collections of information in 21 part 
807, subpart E have been approved under OMB control number 0910-0120; 
and the collections of custom device annual reporting have been 
approved under OMB control number 0910-0767.

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). 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.

VI. Reference

    The following reference has 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 address, but we are not responsible for any 
subsequent changes to the Web site after this document publishes in the 
Federal Register.)
    1. The FDA draft guidance entitled ``Custom Device Exemption,'' 
available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380497.pdf.

    Dated: September 18, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-22683 Filed 9-23-14; 8:45 am]
BILLING CODE 4164-01-P