80 FR 81829 - Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”); Draft Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 251 (December 31, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 251 (December 31, 2015)
| Page Range | 81829-81830 | |
| FR Document | 2015-32920 |
[Federal Register Volume 80, Number 251 (Thursday, December 31, 2015)] [Notices] [Pages 81829-81830] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-32920] ----------------------------------------------------------------------- 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[Docket No. FDA-2015-D-4803] Public Notification of Emerging Postmarket Medical Device Signals (``Emerging Signals''); Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Public Notification of Emerging Postmarket Medical Device Signals (`Emerging Signals').''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 This draft guidance is not final nor is it in effect at this time.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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 29, 2016.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 [email protected] 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
![Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices 81829
Affected Public: State, Local, or Tribal ADDRESSES: You may submit comments copies total. One copy will include the
Governments; Number of Respondents: as follows: information you claim to be confidential
51; Total Annual Responses: 804; Total with a heading or cover note that states
Electronic Submissions
Annual Hours: 8,040. (For policy ‘‘THIS DOCUMENT CONTAINS
questions regarding this collection Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The
contact Camiel Rowe at 410–786–0069.) following way: Agency will review this copy, including
• Federal eRulemaking Portal: http:// the claimed confidential information, in
Dated: December 24, 2015.
www.regulations.gov. Follow the its consideration of comments. The
William N. Parham, III, instructions for submitting comments. second copy, which will have the
Director, Paperwork Reduction Staff, Office Comments submitted electronically, claimed confidential information
of Strategic Operations and Regulatory including attachments, to http://
Affairs. redacted/blacked out, will be available
www.regulations.gov will be posted to for public viewing and posted on
[FR Doc. 2015–32880 Filed 12–30–15; 8:45 am] the docket unchanged. Because your http://www.regulations.gov. Submit
BILLING CODE 4120–01–P comment will be made public, you are both copies to the Division of Dockets
solely responsible for ensuring that your Management. If you do not wish your
comment does not include any name and contact information to be
DEPARTMENT OF HEALTH AND confidential information that you or a
HUMAN SERVICES made publicly available, you can
third party may not wish to be posted, provide this information on the cover
Food and Drug Administration such as medical information, your or sheet and not in the body of your
anyone else’s Social Security number, or comments and you must identify this
[Docket No. FDA–2015–D–4803] confidential business information, such information as ‘‘confidential.’’ Any
as a manufacturing process. Please note information marked as ‘‘confidential’’
Public Notification of Emerging that if you include your name, contact will not be disclosed except in
Postmarket Medical Device Signals information, or other information that accordance with 21 CFR 10.20 and other
(‘‘Emerging Signals’’); Draft Guidance identifies you in the body of your applicable disclosure law. For more
for Industry and Food and Drug comments, that information will be information about FDA’s posting of
Administration Staff; Availability posted on http://www.regulations.gov. comments to public dockets, see 80 FR
AGENCY: Food and Drug Administration, • If you want to submit a comment 56469, September 18, 2015, or access
HHS. with confidential information that you the information at: http://www.fda.gov/
do not wish to be made available to the regulatoryinformation/dockets/
ACTION: Notice. public, submit the comment as a default.htm.
SUMMARY: The Food and Drug written/paper submission and in the Docket: For access to the docket to
Administration (FDA or Agency) is manner detailed (see ‘‘Written/Paper read background documents or the
announcing the availability of the draft Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
guidance entitled ‘‘Public Notification Written/Paper Submissions received, go to http://
of Emerging Postmarket Medical Device www.regulations.gov and insert the
Submit written/paper submissions as docket number, found in brackets in the
Signals (‘Emerging Signals’).’’ This
follows: heading of this document, into the
guidance describes the Agency’s policy • Mail/Hand delivery/Courier (for
for notifying the public about medical ‘‘Search’’ box and follow the prompts
written/paper submissions): Division of and/or go to the Division of Dockets
device ‘‘emerging signals.’’ Historically, Dockets Management (HFA–305), Food
FDA has communicated important Management, 5630 Fishers Lane, Rm.
and Drug Administration, 5630 Fishers 1061, Rockville, MD 20852.
medical device postmarket information Lane, Rm. 1061, Rockville, MD 20852.
after having completed an analysis of An electronic copy of the draft
• For written/paper comments guidance document is available for
available data and, in most cases, after submitted to the Division of Dockets
having reached a decision about download from the Internet. See the
Management, FDA will post your SUPPLEMENTARY INFORMATION section for
relevant recommendations for the comment, as well as any attachments,
device user community and about information on electronic access to the
except for information submitted, guidance. Submit written requests for a
whether further regulatory action is marked and identified, as confidential,
warranted. However, in addition to single hard copy of the draft guidance
if submitted as detailed in document entitled ‘‘Public Notification
these types of public communications, ‘‘Instructions.’’
we believe there also is a need to notify of Emerging Postmarket Medical Device
Instructions: All submissions received
the public about emerging signals that Signals (‘Emerging Signals’)’’ to the
must include the Docket No. FDA–
the Agency is monitoring or analyzing, Office of the Center Director, Guidance
2015–D–4803 for ‘‘Public Notification of
even when the information has not been and Policy Development, Center for
Emerging Postmarket Medical Device
fully analyzed, validated, or confirmed, Devices and Radiological Health, Food
Signals (‘Emerging Signals’).’’ Received
and for which the Agency does not yet and Drug Administration, 10903 New
comments will be placed in the docket
have specific recommendations. This Hampshire Ave., Bldg. 66, Rm. 5431,
and, except for those submitted as
draft guidance is not final nor is it in Silver Spring, MD 20993–0002. Send
‘‘Confidential Submissions,’’ publicly
effect at this time. one self-addressed adhesive label to
viewable at http://www.regulations.gov
DATES: Although you can comment on
assist that office in processing your
or at the Division of Dockets
any guidance at any time (see 21 CFR request.
Management between 9 a.m. and 4 p.m.,
tkelley on DSK3SPTVN1PROD with NOTICES
10.115(g)(5)), to ensure that the Agency Monday through Friday. FOR FURTHER INFORMATION CONTACT:
considers your comment of this draft • Confidential Submissions—To Rebecca Nipper, Center for Devices and
guidance before it begins work on the submit a comment with confidential Radiological Health, Food and Drug
final version of the guidance, submit information that you do not wish to be Administration, 10903 New Hampshire
either electronic or written comments made publicly available, submit your Ave., Bldg. 66, Rm. 1540, Silver Spring,
on the draft guidance by February 29, comments only as a written/paper MD 20993–0002, 301–796–6527.
2016. submission. You should submit two SUPPLEMENTARY INFORMATION:
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![81830 Federal Register / Vol. 80, No. 251 / Thursday, December 31, 2015 / Notices
I. Background it satisfies the requirements of the Institute (NHLBI), the National
All medical devices have benefits and applicable statutes and regulations. Institutes of Health (NIH), will publish
risks. Health care providers, patients, periodic summaries of proposed
III. Electronic Access
and consumers must weigh these projects to the Office of Management
Persons interested in obtaining a copy and Budget (OMB) for review and
benefits and risks when making health
of the draft guidance may do so by approval.
care decisions. FDA weighs probable
downloading an electronic copy from Written comments and/or suggestions
benefit to health from the use of the
the Internet. A search capability for all from the public and affected agencies
device against any probable risk of
Center for Devices and Radiological are invited on one or more of the
injury or illness from such use in
Health guidance documents is available following points: (1) Whether the
determining the safety and effectiveness
at http://www.fda.gov/MedicalDevices/ proposed collection of information is
of a device. However, not all
DeviceRegulationandGuidance/ necessary for the proper performance of
information regarding benefits and risks
GuidanceDocuments/default.htm. the function of the agency, including
for a given device may be fully known
Guidance documents are also available whether the information will have
or characterized prior to the device
at http://www.regulations.gov. Persons practical utility; (2) The accuracy of the
reaching the market. New information
unable to download an electronic copy agency’s estimate of the burden of the
about the safety and/or effectiveness of
of ‘‘Public Notification of Emerging proposed collection of information,
the device often becomes available once
Postmarket Medical Device Signals including the validity of the
the device is more widely distributed
(‘Emerging Signals’)’’ may send an email methodology and assumptions used; (3)
and used under real-world conditions of
request to CDRH-Guidance@fda.hhs.gov Ways to enhance the quality, utility, and
actual clinical practice.
to receive an electronic copy of the clarity of the information to be
FDA is issuing this draft guidance to
document. Please use the document collected; and (4) Ways to minimize the
describe the Agency’s policy for
number 1500027 to identify the burden of the collection of information
notifying the public about medical
guidance you are requesting. on those who are to respond, including
device ‘‘emerging signals.’’ For the
purposes of this guidance, an emerging IV. Paperwork Reduction Act of 1995 the use of appropriate automated,
signal is new information about a electronic, mechanical, or other
This draft guidance refers to technological collection techniques or
medical device used in clinical practice: previously approved collections of
(1) That the Agency is monitoring or other forms of information technology.
information found in FDA regulations.
analyzing, (2) that has the potential to FOR FURTHER INFORMATION CONTACT: To
These collections of information are
impact patient management decisions obtain a copy of the data collection
subject to review by the Office of
and/or alter the known benefit-risk plans and instruments, submit
Management and Budget (OMB) under
profile of the device, (3) that has not yet comments in writing, or request more
the Paperwork Reduction Act of 1995
been fully validated or confirmed, and information on the proposed project,
(44 U.S.C. 3501–3520). The collections
(4) for which the Agency does not yet contact: Paul Sorlie, 6701 Rockledge
of information in 21 CFR parts 801 and
have specific recommendations. Drive, MSC 7936, Bethesda, MD 20892,
808, regarding labelling, have been
We believe there is a need to notify or call non-toll-free number (301) 435–
approved under OMB control number
the public about emerging signals that 0456, or Email your request to: sorliep@
0910–0485 and the collections of
the Agency is monitoring or analyzing, nhlbi.nih.gov. Formal requests for
information in 21 CFR part 803,
even when the information has not been additional plans and instruments must
regarding medical device reporting,
fully analyzed, validated, or confirmed, be requested in writing.
have been approved under OMB control
and for which the Agency does not yet Comments Due Date: Comments
numbers 0910–0291, 0910–0437, and
have specific recommendations. Timely regarding this information collection are
0910–0471.
communication about emerging signals best assured of having their full effect if
is intended to provide health care Dated: December 28, 2015. received within 60 days of the date of
providers, patients, and consumers with Leslie Kux, this publication.
access to the most current information Associate Commissioner for Policy. Proposed Collection: The Framingham
concerning the potential benefits and [FR Doc. 2015–32920 Filed 12–30–15; 8:45 am] Heart Study, Revision, 0925–0216
risks of marketed devices, so that they BILLING CODE 4164–01–P Expiration Date: 10/31/2016, National
can make informed treatment choices Heart, Lung, and Blood Institute
bases on all available information. (NHLBI), the National Institutes of
Therefore, because of the evolving DEPARTMENT OF HEALTH AND Health (NIH).
nature of this information, FDA would HUMAN SERVICES Need and Use of Information
be sharing it with the public at an early Collection: This proposal is to extend
stage of the Agency’s assessment and National Institutes of Health the Framingham Study to examine the
evaluation of the signal. Generation Three Cohort, New Offspring
Proposed Collection; 60 Day Comment Spouses and Omni Group 2 Cohort, as
II. Significance of Guidance Request; The Framingham Heart Study well as to continue to monitor the
This draft guidance is being issued (NHLBI) morbidity and mortality which occurs
consistent with FDA’s good guidance AGENCY: National Institutes of Health, in all Framingham Cohorts. The
practices regulation (21 CFR 10.115). HHS. contractor, with the collaborative
The draft guidance, when finalized, will ACTION: Notice. assistance of NHLBI Intramural staff,
tkelley on DSK3SPTVN1PROD with NOTICES
represent the current thinking of FDA will invite study participants, schedule
on ‘‘Public Notification of Emerging SUMMARY: In compliance with the appointments, administer examinations
Postmarket Medical Device Signals requirement of Section 3506(c)(2)(A) of and testing, enter information into
(‘Emerging Signals’).’’ It does not the Paperwork Reduction Act of 1995, computer databases for editing, and
establish any rights for any person and for opportunity for public comment on prepare scientific reports of the
is not binding on FDA or the public. proposed data collection projects, the information for publication in
You can use an alternative approach if National Heart, Lung, and Blood appropriate scientific journals. All
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Document Created: 2015-12-31 02:14:54
Document Modified: 2015-12-31 02:14:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| 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. | |
| 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. | |
| FR Citation | 80 FR 81829 |
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