Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability, 41418-41420 [2017-18469]
Download as PDF
41418
Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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/201523389.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single hard copy of the draft guidance
document entitled ‘‘Policy Clarification
and Premarket Notification [510(k)]
Submissions for Ultrasonic Diathermy
Devices—Draft Guidance for Industry
and Food and Drug Administration
Staff’’ 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 selfaddressed adhesive label to assist that
office in processing your request.
FOR FURTHER INFORMATION CONTACT:
Jismi Johnson, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1524, Silver Spring,
MD 20993–0002, 301–796–6424.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
20:54 Aug 30, 2017
Jkt 241001
I. Background
Ultrasonic diathermy devices are class
II medical devices regulated under 21
CFR 890.5300(a), Ultrasonic diathermy.
Ultrasonic therapy devices must also
comply with FDA radiation safety
performance standards in 21 CFR part
1010, Performance standards for
electronic products: General, and 21
CFR 1050.10, Ultrasonic therapy
products. FDA recognizes that there are
several IEC standards with which other
countries require conformance or
recognize for ultrasonic therapy
products. This means that
manufacturers, who distribute these
products in both the United States and
other countries, might have to ensure
conformance of their products to IEC
standards and comply with FDA
performance standards. This may cause
manufacturers to duplicate their efforts.
When final, this draft guidance will
clarify FDA’s policy related to
compliance with applicable
performance standards and
conformance to IEC consensus
standards for ultrasonic diathermy
devices. If firms provide a declaration of
conformity with the relevant provisions
of the current FDA recognized versions
of the IEC 60601–2–5 and IEC 61689
standards, FDA does not intend to
consider whether firms comply with
certain requirements of 21 CFR 1050.10.
This draft guidance will also provide
recommendations for information to
provide in 510(k) submissions for
ultrasonic diathermy devices.
at https://www.regulations.gov. Persons
unable to download an electronic copy
of ‘‘Policy Clarification and Premarket
Notification [510(k)] Submissions for
Ultrasonic Diathermy Devices—Draft
Guidance for Industry and Food and
Drug Administration’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 1500003 to identify
the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
The draft guidance also 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 part 807,
subpart E have been approved under
OMB control number 0910–0120; the
collections of information in 21 CFR
part 801 have been approved under
OMB control number 0910–0485; the
collections of information in 21 CFR
part 820 have been approved under
OMB control number 0910–0073; the
collections of information in 21 CFR
parts 1002 through 1050 are approved
under OMB control number 0910–0025.
Dated: August 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–18470 Filed 8–30–17; 8:45 am]
BILLING CODE 4164–01–P
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 policy clarification and premarket
notification (510(k)) submissions for
ultrasonic diathermy 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.
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 https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
Frm 00028
Fmt 4703
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.
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
SUMMARY:
III. Electronic Access
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Sfmt 4703
E:\FR\FM\31AUN1.SGM
31AUN1
Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices
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’’).
sradovich on DSK3GMQ082PROD with NOTICES
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
VerDate Sep<11>2014
20:54 Aug 30, 2017
Jkt 241001
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/201523389.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,
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
41419
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 realworld data (RWD) may constitute realworld 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
E:\FR\FM\31AUN1.SGM
31AUN1
41420
Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices
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.
sradovich on DSK3GMQ082PROD with NOTICES
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 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. 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/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/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
VerDate Sep<11>2014
20:54 Aug 30, 2017
Jkt 241001
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 PreSubmission 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Peer Review of Draft NTP Approach to
Genomic Dose-Response Modeling;
Availability of Documents; Request for
Comments; Notice of Expert Panel
Meeting
The National Toxicology
Program (NTP) announces an expert
panel meeting and is obtaining
comment on a proposed approach to
genomic dose-response modeling. Prior
SUMMARY:
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
to the expert panel meeting, NTP will
host four webinars that present other
approaches to genomic dose-response
modeling. The expert panel meeting and
four webinar presentations leading up to
the meeting are open to the public.
Registration is requested for both inperson meeting attendance and oral
comment; registration is required to
access the meeting webcast. URLs for
live and archived pre-meeting webinars
will be available at https://
ntp.niehs.nih.gov/about/org/
ntpexpertpanel/.
DATES:
Pre-Meeting Webinars: Dates are
posted on the meeting Web site (https://
ntp.niehs.nih.gov/about/org/
ntpexpertpanel/). Registration is not
required to view the pre-meeting
webinars.
Meeting: October 23–25, 2017; expert
panel meeting begins at 8:30 a.m.
Eastern Daylight Time (EDT) each day
and continues until adjournment.
Document Availability: Draft
document should be available by
August 23, 2017, at https://
ntp.niehs.nih.gov/about/org/
ntpexpertpanel/.
Written Public Comment
Submissions: Deadline is October 13,
2017.
Registration for Oral Comments:
Deadline is October 13, 2017.
Registration for Meeting and/or to
View Webcast: Deadline is October 25,
2017. Registration to view the meeting
via webcast is required.
ADDRESSES:
Meeting Location: Rodbell
Auditorium, Rall Building, NIEHS, 111
T.W. Alexander Drive, Research
Triangle Park, NC 27709.
Meeting Web site: The draft
document, preliminary agenda,
registration, pre-meeting webinars
details, and other meeting materials will
be available at https://ntp.niehs.nih.gov/
about/org/ntpexpertpanel/.
Webcast: The URL for viewing the
expert panel meeting webcast will be
provided to those who register.
FOR FURTHER INFORMATION CONTACT:
Anna Stamatogiannakis, ICF, 2635
Meridian Parkway, Suite 200, Durham,
NC, USA 27713. Phone: (919) 293–1652,
Fax: (919) 293–1645, Email:
anna.stamatogiannakis@icf.com.
SUPPLEMENTARY INFORMATION:
Background: NTP proposes to use the
approach embodied in the BMDExpress
software to perform gene and pathwaylevel genomic dose-response modeling
as part of Tox21 Phase 3 and in vivo
screening level studies. NTP seeks
external scientific input on its proposed
approach by an expert panel. NTP’s goal
E:\FR\FM\31AUN1.SGM
31AUN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
[[Page 41420]]
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