[Federal Register Volume 78, Number 131 (Tuesday, July 9, 2013)]
[Notices]
[Pages 41069-41070]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-16395]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0743]


Medical Device Reporting for Manufacturers; Draft Guidance for 
Industry and Food and Drug Administration Staff; 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availability of the draft guidance entitled ``Medical Device Reporting 
for Manufacturers.'' This draft guidance describes and explains the 
current FDA regulation that addresses reporting and recordkeeping 
requirements applicable to manufacturers of medical devices for certain 
device-related adverse events. This draft guidance is intended to 
update FDA's policy and to further clarify FDA's interpretations of the 
regulation requirements and, when final, will supersede the previous 
manufacturer guidances issued in 1988 and 1997. This draft guidance 
also provides answers to frequently asked questions and includes a 
section on common reporting errors. This draft guidance is not final 
nor is it in effect at this time.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 7, 2013.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Medical Device Reporting for 
Manufacturers'' 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. Please use the document number 1828 to 
identify the guidance you are requesting. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Barbara Myklebust, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 2312, Silver Spring, MD 20993-0002, 301-
796-6005.

SUPPLEMENTARY INFORMATION:

I. Background

    The first Medical Device Reporting (MDR) regulation became 
effective December 13, 1984, with mandatory device-related adverse 
event reporting obligations for manufacturers and importers. FDA 
published ``Medical Device Reporting Questions and Answers'' as part of 
its Compliance Guidance Series in February 1988. Subsequent changes to 
the reporting requirements, including mandatory reporting by domestic 
distributors and device user facilities, resulted from amendments to 
the Federal Food Drug and Cosmetic Act (the FD&C Act) in 1990 and 1992.
    The MDR regulation was revised significantly after the 1990 and 
1992 amendments to the FD&C Act. The amended MDR regulation was 
published with significant revisions on December 11, 1995, and 
effective on July 31, 1996. FDA published a guidance document ``Medical 
Device Reporting for Manufacturers'' in March 1997 to clarify the 
changes to reporting requirements under the new regulation. The FD&C 
Act was further modified by amendments in 1997, 2002, and 2007, 
requiring further changes to the regulation. A plain language version 
of the MDR regulation was published on February 28, 2005, effective (in 
part) on July 13, 2005.
    This draft guidance describes and explains the current FDA 
regulation that addresses reporting and recordkeeping requirements 
applicable to manufacturers of medical devices for certain device-
related adverse events. This draft guidance is intended to update FDA's 
policy and to further clarify FDA's interpretations of the regulation 
requirements and, when final, will supersede the previous manufacturer 
guidances issued in 1988 and 1997. The draft guidance also provides 
answers to frequently asked questions and includes a section on common 
reporting errors.

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 medical 
device reporting for manufacturers. 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. A search capability for all Center for 
Devices and Radiological Health guidance documents is available at 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at 
http://www.regulations.gov. To receive ``Medical Device Reporting for 
Manufacturers,'' 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 1828 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft 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 
collection of information in 21 CFR part 803 subparts A to E have been 
approved under OMB 0910-0437 (expires August 31, 2015), and the 
collection of information in 21 CFR 803.11 and 803.20 have been 
approved under OMB control number 0910-0291 (expires June 30, 2015).

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. It is necessary to send only one set of 
comments. Identify comments with the docket number found in brackets in 
the heading of this document. Received comments may be

[[Page 41070]]

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: July 1, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-16395 Filed 7-8-13; 8:45 am]
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