[Federal Register Volume 81, Number 144 (Wednesday, July 27, 2016)]
[Notices]
[Pages 49228-49230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-17750]


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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 Decisionmaking 
for Medical Devices; Draft Guidance for Industry and Food and Drug 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the availability of the draft guidance entitled ``Use of Real-World 
Evidence to Support Regulatory Decisionmaking for Medical Devices.'' 
FDA is issuing this draft guidance to clarify how we evaluate real-
world data (RWD) to determine whether it may be sufficiently relevant 
and reliable to generate the types of real-world evidence that can be 
used in regulatory decisionmaking for medical devices. This guidance 
also clarifies when an

[[Page 49229]]

investigational device exemption (IDE) may be needed to prospectively 
collect and use RWD for purposes of determining the safety and 
effectiveness of a device. This draft guidance is not final nor is it 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by October 25, 2016.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-2016-D-2153 for ``Use of Real-World Evidence to Support Regulatory 
Decisionmaking for Medical Devices.'' 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 draft guidance document entitled 
``Use of Real-World Evidence to Support Regulatory Decisionmaking 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. 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.

SUPPLEMENTARY INFORMATION:

I. Background

    To protect and promote the 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 RWD 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 decisionmaking.
    This document describes the characteristics and sources of RWD 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 decisionmaking are not changing; 
FDA will evaluate whether the available RWD is 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 real-world evidence and that 
provide protections for human subjects or patient privacy. When 
finalized, this guidance should be used to complement, but not 
supersede, other device-specific and good clinical practice guidance 
documents.

[[Page 49230]]

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 ``Use of Real-
World Evidence to Support Regulatory Decisionmaking 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.

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 ``Use of Real-World Evidence 
to Support Regulatory Decisionmaking 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 part 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 part 56.115 (IRB records) have 
been approved under OMB control number 0910-0130; and the collections 
of information in 21 CFR parts 50 (informed consent) and 56 (IRBs) 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: July 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-17750 Filed 7-26-16; 8:45 am]
BILLING CODE 4164-01-P