
[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 CDRH-Guidance@fda.hhs.gov 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]
BILLING CODE 4164-01-P


