
[Federal Register Volume 77, Number 223 (Monday, November 19, 2012)]
[Notices]
[Page 69488]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28042]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1045]


Medical Devices; Custom Devices; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration Safety and Innovation Act 
(FDASIA), which was signed into law on July 9, 2012, amended the 
Federal Food, Drug, and Cosmetic Act (the FD&C Act). The Food and Drug 
Administration (FDA) is in the process of developing an implementation 
strategy and policy for the custom device exemption criteria in the 
FD&C Act amended by FDASIA. FDA is seeking information on appropriate 
uses of the custom device exemption.

DATES: Submit either electronic or written comments by January 18, 
2013.

ADDRESSES: Submit electronic comments 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.

FOR FURTHER INFORMATION CONTACT: Bryan Benesch, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3424, Silver Spring, MD 20993-0002, 301-796-5506.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 520(b) of the FD&C Act (21 U.S.C. 360j(b), as amended by 
section 617 of FDASIA (Pub. L. 112-144), sets forth the requirements 
that must be met in order for a device to qualify for a custom device 
exemption (Ref. 1). Section 520(b) of the FD&C Act exempts ``custom 
devices'' from performance standard or premarket approval requirements 
under sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e), 
if these devices meet the enumerated statutory requirements, including, 
among others, the following for each device: (1) Is ``created or 
modified in order to comply with the order of an individual physician 
or dentist (or any other specially qualified person designated under 
regulations promulgated by the Secretary after an opportunity for an 
oral hearing)''; (2) must not be ``generally available in the United 
States in finished form through labeling or advertising by the 
manufacturer, importer, or distributor for commercial distribution''; 
(3) must be for the purpose of treating a ``unique pathology or 
physiological condition that no other device is domestically available 
to treat''; and (4) must be manufactured for the ``special needs of 
such physician or dentist (or other specially qualified person so 
designated) in the course of the professional practice of the physician 
or dentist (or other specially qualified person so designated)'' or by 
an individual patient named in such order.
    In addition to these new requirements for establishing a custom 
device, manufacturers will have limitations for use of a custom device 
only for the purpose of treating a ``sufficiently rare condition, such 
that conducting clinical investigations on such device would be 
impracticable'' and production of the device must be limited to no more 
than five units per year of a particular device type. Lastly, 
manufacturers will be required to submit an annual report explaining 
their use of the custom device exemption under section 617 of FDASIA.
    FDA is seeking information on and examples of appropriate uses of 
the custom device exemption identified in section 520(b) of the FD&C 
Act. FDA encourages all stakeholders, including patients, physicians, 
dentists, and manufacturers, to submit comments on the appropriate use 
of this statutory provision.
    FDA is particularly interested in receiving information relating 
to:
    1. Input from patients, manufacturers, dentists, or physicians on 
where use of the custom device exemption is appropriate.
    2. Specific instances where manufacturers, dentists, or physicians 
have used, would have liked to use, or plan to use the custom device 
exemption for treatment of a sufficiently rare condition.
    3. Product areas other than orthopedic and dental devices where the 
custom device exemption may be useful.
    4. The type of information manufacturers intend to require a 
physician, dentist, or other qualified person to submit to them when 
ordering a custom device.
    5. How often a custom device is ordered due to unusual anatomical 
features of the individual physician/dentist, or due to a unique need 
in the physician's/dentist's practice not shared by health 
professionals of the same specialty (i.e., a special need of a 
physician or dentist).
    This notice provides the first opportunity for the public to 
comment on these issues. The public will have a second opportunity to 
provide input when the Agency announces the availability of a draft 
guidance document and a draft regulation for implementing section 
520(b) of the FD&C Act.

II. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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.

III. 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, and are 
available electronically at http://www.regulations.gov.
    1. The Food and Drug Administration Safety and Innovation Act, 
available at http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm20027187.htm.

    Dated: November 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28042 Filed 11-16-12; 8:45 am]
BILLING CODE 4160-01-P


