Document ID: FDA-2008-D-0395-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry, User Facilities, and Food and Drug Administration Staff; eMDR-Electronic Medical Device Reporting; Availability
Posted Date: 2009-08-21T04:00Z

[Federal Register: August 21, 2009 (Volume 74, Number 161)]
[Notices]               
[Page 42310]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21au09-60]                         

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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Draft Guidance for Industry, User Facilities, and Food and Drug 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availability of the draft guidance entitled ``eMDR--Electronic Medical 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 The draft guidance document addresses general 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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``eMDR--Electronic Medical Device 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comments concerning this draft guidance to the Division of Dockets 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 dsmica@fda.hhs.gov 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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