[Federal Register Volume 79, Number 31 (Friday, February 14, 2014)]
[Notices]
[Pages 8977-8978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03276]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0393]


Questions and Answers About 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 guidance entitled ``Questions and Answers About 
eMDR--Electronic Medical Device Reporting.'' FDA has published a final 
rule that requires device manufacturers and importers to submit 
mandatory reports of individual medical device adverse events, also 
known as medical device reports (MDRs), to the Agency in an electronic 
format that FDA can process, review and archive. This guidance provides 
general information regarding how to prepare and send an electronic 
postmarket medical device report to the Center for Devices and 
Radiological Health (CDRH) in FDA. The guidance also identifies where 
to find more detailed information on the preparation and transmission 
of the reports.

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:  Submit written requests for single copies of the guidance 
document entitled ``Questions and Answers About 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., Bldg. 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 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: Tahseen Mirza, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2312, Silver Spring, MD 20993-0002, 301-796-7645.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 519 of the Federal Food, Drug and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 360i) is FDA's authorization to issue a regulation to 
require mandatory reporting of device-related adverse events. The 
Medical Device Reporting (MDR) regulation, 21 CFR part 803, effective 
December 13, 1984, contained reporting requirements for device 
manufacturers and importers. Amendments to the FD&C Act under the Safe 
Medical Devices Act of 1990 and the Medical Device Amendments of 1992 
introduced mandatory reporting by device user facilities and changed 
the requirements for device manufacturers, importers and distributors. 
FDA revised the MDR regulation (part 803) effective July 31, 1996, to 
address the reporting changes. On February 28, 2005, FDA revised the 
MDR regulation into plain language.
    On August 21, 2009, FDA published a proposed rule (74 FR 42203) to 
amend part 803 to require manufacturers, importers, and user facilities 
to submit MDRs to the Agency in an electronic format. Because of 
concerns over the cost of implementation for user facilities, and the 
relatively low volume of reports FDA receives from such facilities, the 
final rule does not require user facilities to adopt electronic 
reporting. Although FDA encourages user facilities to file reports 
electronically, they may continue to use only paper forms for MDR 
reporting. The final rule for electronic submission of MDRs to FDA 
anticipates that there will be a reduction in costs and time associated 
with the submission of MDR reports, elimination of transcription errors 
associated with paper reports, and both expedited access to safety 
information and enhanced ability to communicate information about 
suspected problems. This question and answer guidance provides general 
information on how to prepare and send an electronic postmarket medical 
device report to FDA and identifies where to find more detailed 
information on how to prepare and transmit eMDRs.
    The draft eMDR guidance document was published in the Federal 
Register of August 21, 2009. No significant comments were received.

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 electronic MDR reporting. 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 guidance may do so by 
using the Internet. To receive ``Questions and Answers about eMDR--
Electronic Medical Device Reporting,'' you may either send an email 
request to [email protected] to receive an electronic copy of the 
document or send a fax request to 301-847-8149 to receive a hard copy. 
Please use the document number 1679 to identify the guidance you are 
requesting. A search capability for all CDRH guidance documents is 
available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 803 have been approved under 
OMB control numbers 0910-0291 and 0910-0437.

[[Page 8978]]

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). 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.

    Dated: February 11, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-03276 Filed 2-13-14; 8:45 am]
BILLING CODE 4160-01-P