[Federal Register Volume 82, Number 168 (Thursday, August 31, 2017)]
[Notices]
[Pages 41418-41420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18469]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-2153]
Use of Real-World Evidence To Support Regulatory Decision-Making
for Medical Devices; 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 ``Use of Real-World Evidence
to Support Regulatory Decision-Making for Medical Devices.'' FDA is
issuing this guidance to clarify how we evaluate real-world data to
determine whether it may be sufficiently relevant and reliable to
generate the types of real-world evidence that can be used in FDA
[[Page 41419]]
regulatory decision-making for medical devices. The guidance describes
the circumstances when real-world evidence can be used, and the
scientific criteria that must be fulfilled in order to have confidence
in the data. Finally, the guidance describes some examples of actual
uses of real-world evidence that have already led to FDA decisions.
DATES: The announcement of the guidance is published in the Federal
Register on August 31, 2017.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2016-D-2153 for ``Use of Real-World Evidence to Support Regulatory
Decision-Making for Medical Devices; Guidance for Industry and Food and
Drug Administration Staff.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff office 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 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 ``Use
of Real-World Evidence to Support Regulatory Decision-Making for
Medical Devices'' 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; or the Office of Communication, Outreach,
and Development, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT: Benjamin Eloff, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2254, Silver Spring, MD 20993-0002, 301-796-8528;
and Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
To protect and promote public health, FDA needs to understand and
evaluate the available evidence related to regulated products. For
medical devices, available evidence is traditionally comprised of non-
clinical and in some cases, clinical studies conducted and provided to
FDA by the device manufacturer or sponsor. However, FDA recognizes that
a wealth of data covering medical device experience exists and is
routinely collected in the course of treatment and management of
patients. Under certain circumstances, these real-world data (RWD) may
constitute real-world evidence (RWE), or clinical evidence regarding
the usage and potential benefits or risks of a medical product derived
from analysis of RWD, that may be of sufficient quality to help inform
or augment FDA's understanding of the benefit-risk profile of devices
at various points in their life cycle, and could potentially be used to
aid FDA in regulatory decision-making.
This document describes the characteristics and sources of RWD and
characteristics of RWE that may be sufficient for use in making various
regulatory decisions. Because of its nature, the quality (i.e.,
relevance and reliability) of RWD can vary greatly across sources.
Likewise, there are many types of regulatory decisions with varying
levels of evidentiary needs. FDA's evidentiary standards for regulatory
decision-making are not changing. FDA encourages the use of RWE where
appropriate, and will evaluate whether the available RWE is
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of sufficient relevance and reliability to address the specific
regulatory decision being considered.
This guidance does not affect any Federal, State or local laws or
regulations or foreign laws or regulations that may otherwise be
applicable to the use or collection of RWE and that provide protections
for human subjects or patient privacy. This guidance should be used to
complement, but not supersede, other device-specific and good clinical
practice guidance documents. FDA considered comments received on the
draft guidance that published in the Federal Register of July 27, 2016
(81 FR 49228). FDA revised the guidance as appropriate in response to
the comments.
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 use of real-world evidence to support
regulatory decision-making for medical devices. 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. This guidance is not subject to
Executive Order 12866.
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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or https://www.regulations.gov. Persons unable to download
an electronic copy of ``Use of Real-World Evidence to Support
Regulatory Decision-Making for Medical Devices'' may send an email
request to [email protected] to receive an electronic copy of
the document. Please use the document number 1500012 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 and guidance. 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 part 807, subpart E,
have been approved under OMB control number 0910-0120; the collections
of information in 21 CFR part 814, subparts A through E (premarket
approval), have been approved under OMB control number 0910-0231; the
collections of information in 21 CFR part 814, subpart H (humanitarian
device exemption), have been approved under OMB control number 0910-
0332; the collections of information in 21 CFR part 812
(investigational device exemption) have been approved under OMB control
number 0910-0078; the collections of information in 21 CFR part 822
(postmarket surveillance) have been approved under OMB control number
0910-0449; the collections of information in 21 CFR 50.23 (exception
from general requirements for informed consent) have been approved
under OMB control number 0910-0586; the collections of information in
21 CFR part 54 (financial disclosure by clinical investigators) have
been approved under OMB control number 0910-0396; the collections of
information in 21 CFR 56.115 (institutional review boards records) have
been approved under OMB control number 0910-0130; and the collections
of information in 21 CFR parts 50 subpart B (informed consent of human
subjects) and 56 (institutional review boards) have been approved under
OMB control number 0910-0755. The collections of information in the
guidance ``Requests for Feedback on Medical Device Submissions: The
Pre-Submission Program and Meetings with Food and Drug Administration
Staff'' have been approved under OMB control number 0910-0756.
Dated: August 25, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-18469 Filed 8-30-17; 8:45 am]
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