
[Federal Register Volume 81, Number 240 (Wednesday, December 14, 2016)]
[Notices]
[Pages 90365-90367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29989]


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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''); 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 or Agency) is announcing 
the availability of the guidance entitled ``Public Notification of 
Emerging Postmarket Medical Device Signals (`Emerging Signals').'' FDA 
is issuing this guidance to describe the Center for Devices and 
Radiological Health's (CDRH) policy for notifying the public about 
medical device ``emerging signals.'' This guidance describes the

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factors CDRH intends to consider in deciding whether to notify the 
public about an emerging signal and the processes and timelines it 
intends to follow in issuing and updating the notification. Timely 
notification about those emerging signals based on the factors 
described in this guidance document is intended to provide health care 
providers, patients, and consumers with access to the most current 
information concerning the performance and potential benefits and risks 
of marketed medical devices so that they can make informed patient 
management decisions about their treatment and diagnostic options.

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 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 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 
``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: 

I. Background

    All medical devices have benefits and risks. 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.\1\ Once FDA has made its determination, 
health care providers, patients, and consumers must weigh these 
benefits and risks when making patient management decisions. However, 
not all information regarding benefits and risks for a given device may 
be known before the device reaches the market. New information about a 
device's safety and/or effectiveness, including unanticipated adverse 
events, may become available once the device is more widely distributed 
and used under real-world conditions and in broader patient populations 
than may have been studied in support of a marketing application. Also, 
subsequent changes made to the device, its manufacturing process, or 
supply chain might lead to new safety problems.
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    \1\ See 21 U.S.C. 360c(a)(2) and 21 CFR 860.7.
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    FDA is issuing this guidance to describe CDRH policy for notifying 
the public about medical device ``emerging signals.'' For the purposes 
of this guidance, an emerging signal is new information about a 
marketed medical device: (1) That supports a new causal association or 
a new aspect of a known association between a device and an adverse 
event or set of adverse events and (2) for which the Agency has 
conducted an initial evaluation and determined that the information has 
the potential to impact patient management decisions and/or the known 
benefit-risk profile of the device. Information that is

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unconfirmed, unreliable, or lacks sufficient strength of evidence is 
not an emerging signal.
    This guidance describes the factors CDRH intends to consider in 
deciding whether to notify the public about emerging signals and the 
processes and timelines it intends to follow in issuing and updating 
the notification. Timely notification about those emerging signals 
based on the factors described in this guidance document is intended to 
provide health care providers, patients, and consumers with access to 
the most current information concerning the performance and potential 
benefits and risks of marketed medical devices so that they can make 
informed patient management decisions about their treatment and 
diagnostic options.
    In the Federal Register of December 31, 2015 (80 FR 81829), FDA 
announced the availability of the draft of this guidance. Interested 
persons were invited to comment by February 29, 2016. In the Federal 
Register of January 27, 2016 (81 FR 4632), FDA extended the comment 
period to March 29, 2016. FDA received and considered 21 sets of public 
comments and revised the guidance as appropriate. CDRH also intends to 
provide periodic public updates on the implementation of this guidance.

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 ``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 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 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, regarding labeling, 
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 9, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-29989 Filed 12-13-16; 8:45 am]
 BILLING CODE 4164-01-P


