[Federal Register Volume 74, Number 161 (Friday, August 21, 2009)]
[Notices]
[Page 42310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19681]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0395]
Draft Guidance for Industry, User Facilities, and Food and Drug
Administration Staff; eMDR--Electronic Medical Device Reporting;
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availability of the draft guidance entitled ``eMDR--Electronic Medical
Device Reporting.'' The draft guidance document addresses general
issues related to the submission of postmarket medical device reports
(MDRs) in electronic format. Elsewhere in this issue of the Federal
Register, FDA is publishing a proposed rule to require that
manufacturers, importers, and user facilities submit most MDRs to the
agency in electronic format.
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 on
this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by November 19, 2009.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``eMDR--Electronic Medical Device
Reporting'' to the Division of Small Manufacturers, International, and
Consumer Assistance , Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Building 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 301-847-8149. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance. Submit written
comments concerning this draft guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify comments with the docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Howard Press, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Building 66, rm. 3320, Silver Spring, MD 20993-0002, 301-796-
6087.
SUPPLEMENTARY INFORMATION:
I. Background
The draft guidance document provides information related to the
submission of postmarket MDRs in electronic format, including technical
information. The information provided in the draft guidance document is
intended to help reporters prepare the MDR for electronic submission in
a way that would satisfy the requirements of FDA's proposed electronic
Medical device reporting regulation that is published elsewhere in this
issue of the Federal Register.
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 electronic
medical device reporting (eMDR). 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. To receive an electronic copy of ``eMDR--
Electronic Medical Device Reporting'' you may either send an e-mail
request to [email protected] or send a fax request to 240-276-3151 to
receive a hard copy. Please use the document number 1679 to identify
the guidance you are requesting.
The Center for Devices and Radiological Health (CDRH) maintains an
entry on the Internet for easy access to information including text,
graphics, and files that may be downloaded to a personal computer with
Internet access. Updated on a regular basis, the CDRH home page
includes device safety alerts, Federal Register reprints, information
on premarket submissions (including lists of approved applications and
manufacturers' addresses), small manufacturer's assistance, information
on video conferencing and electronic submissions, Mammography Matters,
and other device-oriented information. The CDRH Web site may be
accessed at http://www.fda.gov/cdrh. A search capability for all CDRH
guidance documents is available at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of
Dockets Management Internet site at http://www.regulations.gov.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to proposed collections of information
described in FDA's proposed rule on medical device reporting,
electronic submission requirements, published elsewhere in this issue
of the Federal Register. The proposed collections of information in the
proposed rule are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C.
3501-3520). In accordance with the proposed medical device regulation,
medical device manufacturers, importers, and user facilities would be
required to submit MDRs to FDA, to maintain records, and may also seek
exemption or variance from these requirements. Manufacturers, importer,
and user facilities are currently submitting paper MDR reports on FDA
Form 3500 A, for which the existing information collection requirements
under 21 CFR part 803 are approved under OMB control number 0910-0437.
The changes to the burden associated with this proposed rule have been
sent to OMB as a revision to OMB control number 0910-0437 for review
under section 307(d) of the PRA.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), written or electronic comments regarding this
document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified 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.
Dated: August 11, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-19681 Filed 8-20-09; 8:45 am]
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