[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)]
[Notices]
[Pages 78603-78605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26933]


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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; Guidance for Industry 
and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Medical Device Reporting for 
Manufacturers; Guidance for Industry and Food and Drug Administration 
Staff.'' This guidance document is intended to assist medical device 
manufacturers meet applicable reporting and recordkeeping requirements 
for certain device-related adverse events and malfunctions.

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: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov/ 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note

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that if you include your name, contact information, or other 
information that identifies you in the body of your comments, that 
information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-D-0743 for ``Medical Device Reporting for Manufacturers''. 
Received comments will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Medical Device Reporting for Manufacturers'' to the Office of the 
Center Director, Guidance and Policy Development, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your request.

FOR FURTHER INFORMATION CONTACT: Isaac Chang, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 3114, Silver Spring, MD 20993-0002, 301-796-2789.

SUPPLEMENTARY INFORMATION: 

I. Background

    Medical device reporting under section 519(a) of the Federal Food 
Drug, and Cosmetic Act (21 U.S.C. 360i(a)) provides a mechanism that 
allows FDA and device manufacturers, user facilities, and importer of 
medical devices to identify and monitor adverse events (deaths and 
serious injuries) and certain malfunctions involving your medical 
devices. The goal is to detect and correct problems in a timely manner. 
This guidance updates FDA's policy and clarifies FDA's interpretations 
of the regulatory requirements under part 803 (21 CFR part 803) and 
includes a section on common reporting errors.
    The draft of this guidance was made available in the Federal 
Register on July 9, 2013 (78 FR 41069), and the comment period closed 
October 7, 2013. FDA reviewed and considered all public comments 
received and revised the guidance as appropriate.
    This document supersedes the draft entitled, ``Medical Device 
Reporting for Manufacturers; Guidance for Industry and Food and Drug 
Administration Staff,'' dated July 9, 2013, and the previous guidance 
on this topic, ``Medical Device Reporting for Manufacturers,'' issued 
March 1997.

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 
current thinking of FDA on medical device reporting. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from 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. Persons 
unable to download an electronic copy of ``Medical Device Reporting for 
Manufacturers; Guidance for Industry and Food and Drug Administration 
Staff'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the document 
number 1828 to identify the guidance you are requesting.

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 parts 801 and 809, regarding 
labeling, have been approved under OMB control number 0910-0485; the 
collections of information in part 803, regarding medical device 
reporting, have been approved under OMB control number 0910-0437; the 
collections of information in 21 CFR part 806, regarding corrections 
and removals, have been approved under OMB control number 0910-0359; 
the collections of information in 21 CFR part 807, subpart E, regarding 
premarket notification,

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have been approved under OMB control number 0910-0120; the collections 
of information in 21 CFR part 812, regarding investigational device 
exemptions, have been approved under OMB control number 0910-0078; the 
collections of information in 21 CFR part 814, subparts A through E, 
regarding premarket approval, have been approved under OMB control 
number 0910-0231; the collections of information in 21 CFR part 820, 
regarding quality system regulations, have been approved under OMB 
control number 0910-0073; the collections of information regarding 
MedWatch: The Food and Drug Administration Medical Products Reporting 
Program have been approved under OMB control number 0910-0291; and the 
collections of information regarding the Adverse Event Program for 
Medical Devices (Medical Product Safety Network (MedSun)) have been 
approved under OMB control number 0910-0471.

    Dated: November 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-26933 Filed 11-7-16; 8:45 am]
 BILLING CODE 4164-01-P