[Federal Register Volume 77, Number 223 (Monday, November 19, 2012)]
[Notices]
[Page 69488]
From the Federal Register Online via the Government Publishing 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]
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