
[Federal Register Volume 80, Number 251 (Thursday, December 31, 2015)]
[Notices]
[Pages 81829-81830]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32920]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4803]


Public Notification of Emerging Postmarket Medical Device Signals 
(``Emerging Signals''); Draft Guidance for Industry and Food and Drug 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 or Agency) is announcing 
the availability of the draft guidance entitled ``Public Notification 
of Emerging Postmarket Medical Device Signals (`Emerging Signals').'' 
This guidance describes the Agency's policy for notifying the public 
about medical device ``emerging signals.'' Historically, FDA has 
communicated important medical device postmarket information after 
having completed an analysis of available data and, in most cases, 
after having reached a decision about relevant recommendations for the 
device user community and about whether further regulatory action is 
warranted. However, in addition to these types of public 
communications, we believe there also is a need to notify the public 
about emerging signals that the Agency is monitoring or analyzing, even 
when the information has not been fully analyzed, validated, or 
confirmed, and for which the Agency does not yet have specific 
recommendations. This draft guidance is not final nor is it in effect 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 of 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 29, 2016.

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 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-2015-D-4803 for ``Public Notification of Emerging Postmarket 
Medical Device Signals (`Emerging Signals').'' 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 draft 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 draft guidance document entitled 
``Public Notification of Emerging Postmarket Medical Device Signals 
(`Emerging Signals')'' 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: Rebecca Nipper, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527.

SUPPLEMENTARY INFORMATION: 

[[Page 81830]]

I. Background

    All medical devices have benefits and risks. Health care providers, 
patients, and consumers must weigh these benefits and risks when making 
health care decisions. FDA weighs probable benefit to health from the 
use of the device against any probable risk of injury or illness from 
such use in determining the safety and effectiveness of a device. 
However, not all information regarding benefits and risks for a given 
device may be fully known or characterized prior to the device reaching 
the market. New information about the safety and/or effectiveness of 
the device often becomes available once the device is more widely 
distributed and used under real-world conditions of actual clinical 
practice.
    FDA is issuing this draft guidance to describe the Agency's policy 
for notifying the public about medical device ``emerging signals.'' For 
the purposes of this guidance, an emerging signal is new information 
about a medical device used in clinical practice: (1) That the Agency 
is monitoring or analyzing, (2) that has the potential to impact 
patient management decisions and/or alter the known benefit-risk 
profile of the device, (3) that has not yet been fully validated or 
confirmed, and (4) for which the Agency does not yet have specific 
recommendations.
    We believe there is a need to notify the public about emerging 
signals that the Agency is monitoring or analyzing, even when the 
information has not been fully analyzed, validated, or confirmed, and 
for which the Agency does not yet have specific recommendations. Timely 
communication about emerging signals is intended to provide health care 
providers, patients, and consumers with access to the most current 
information concerning the potential benefits and risks of marketed 
devices, so that they can make informed treatment choices bases on all 
available information. Therefore, because of the evolving nature of 
this information, FDA would be sharing it with the public at an early 
stage of the Agency's assessment and evaluation of the signal.

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 current thinking of FDA on ``Public 
Notification of Emerging Postmarket Medical Device Signals (`Emerging 
Signals').'' 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 draft 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 ``Public Notification of 
Emerging Postmarket Medical Device Signals (`Emerging Signals')'' may 
send an email request to CDRH-Guidance@fda.hhs.gov to receive an 
electronic copy of the document. Please use the document number 1500027 
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 
collections of information in 21 CFR parts 801 and 808, regarding 
labelling, have been approved under OMB control number 0910-0485 and 
the collections of information in 21 CFR part 803, regarding medical 
device reporting, have been approved under OMB control numbers 0910-
0291, 0910-0437, and 0910-0471.

    Dated: December 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32920 Filed 12-30-15; 8:45 am]
BILLING CODE 4164-01-P


