82 FR 41418 - Use of Real-World Evidence To Support Regulatory Decision-Making for Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 168 (August 31, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 168 (August 31, 2017)
| Page Range | 41418-41420 | |
| FR Document | 2017-18469 |
[Federal Register Volume 82, Number 168 (Thursday, August 31, 2017)] [Notices] [Pages 41418-41420] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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 [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] BILLING CODE 4164-01-P
![41418 Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices
CONFIDENTIAL INFORMATION.’’ The I. Background at https://www.regulations.gov. Persons
Agency will review this copy, including Ultrasonic diathermy devices are class unable to download an electronic copy
the claimed confidential information, in II medical devices regulated under 21 of ‘‘Policy Clarification and Premarket
its consideration of comments. The CFR 890.5300(a), Ultrasonic diathermy. Notification [510(k)] Submissions for
second copy, which will have the Ultrasonic therapy devices must also Ultrasonic Diathermy Devices—Draft
claimed confidential information Guidance for Industry and Food and
comply with FDA radiation safety
redacted/blacked out, will be available Drug Administration’’ may send an
performance standards in 21 CFR part
for public viewing and posted on email request to CDRH-Guidance@
1010, Performance standards for
https://www.regulations.gov. Submit fda.hhs.gov to receive an electronic
electronic products: General, and 21
both copies to the Dockets Management copy of the document. Please use the
CFR 1050.10, Ultrasonic therapy
Staff. If you do not wish your name and document number 1500003 to identify
products. FDA recognizes that there are
contact information to be made publicly the guidance you are requesting.
several IEC standards with which other
available, you can provide this countries require conformance or IV. Paperwork Reduction Act of 1995
information on the cover sheet and not recognize for ultrasonic therapy The draft guidance also refers to
in the body of your comments and you products. This means that previously approved collections of
must identify this information as manufacturers, who distribute these information found in FDA regulations.
‘‘confidential.’’ Any information marked products in both the United States and These collections of information are
as ‘‘confidential’’ will not be disclosed other countries, might have to ensure subject to review by the Office of
except in accordance with 21 CFR 10.20 conformance of their products to IEC Management and Budget (OMB) under
and other applicable disclosure law. For standards and comply with FDA the Paperwork Reduction Act of 1995
more information about FDA’s posting performance standards. This may cause (44 U.S.C. 3501–3520). The collections
of comments to public dockets, see 80 manufacturers to duplicate their efforts. of information in 21 CFR part 807,
FR 56469, September 18, 2015, or access When final, this draft guidance will subpart E have been approved under
the information at: https://www.gpo.gov/ clarify FDA’s policy related to OMB control number 0910–0120; the
fdsys/pkg/FR-2015-09-18/pdf/2015- compliance with applicable collections of information in 21 CFR
23389.pdf. performance standards and part 801 have been approved under
conformance to IEC consensus OMB control number 0910–0485; the
Docket: For access to the docket to standards for ultrasonic diathermy collections of information in 21 CFR
read background documents or the devices. If firms provide a declaration of part 820 have been approved under
electronic and written/paper comments conformity with the relevant provisions OMB control number 0910–0073; the
received, go to https:// of the current FDA recognized versions collections of information in 21 CFR
www.regulations.gov and insert the of the IEC 60601–2–5 and IEC 61689 parts 1002 through 1050 are approved
docket number, found in brackets in the standards, FDA does not intend to under OMB control number 0910–0025.
heading of this document, into the consider whether firms comply with Dated: August 28, 2017.
‘‘Search’’ box and follow the prompts certain requirements of 21 CFR 1050.10.
Leslie Kux,
and/or go to the Dockets Management This draft guidance will also provide
Staff, 5630 Fishers Lane, Rm. 1061, Associate Commissioner for Policy.
recommendations for information to
Rockville, MD 20852. [FR Doc. 2017–18470 Filed 8–30–17; 8:45 am]
provide in 510(k) submissions for
ultrasonic diathermy devices. BILLING CODE 4164–01–P
An electronic copy of the guidance
document is available for download II. Significance of Guidance
from the internet. See the DEPARTMENT OF HEALTH AND
SUPPLEMENTARY INFORMATION section for
This draft guidance is being issued
consistent with FDA’s good guidance HUMAN SERVICES
information on electronic access to the
practices regulation (21 CFR 10.115). Food and Drug Administration
guidance. Submit written requests for a
The draft guidance, when finalized, will
single hard copy of the draft guidance [Docket No. FDA–2016–D–2153]
represent the current thinking of FDA
document entitled ‘‘Policy Clarification
on policy clarification and premarket
and Premarket Notification [510(k)] Use of Real-World Evidence To
notification (510(k)) submissions for
Submissions for Ultrasonic Diathermy Support Regulatory Decision-Making
ultrasonic diathermy devices. It does
Devices—Draft Guidance for Industry not establish any rights for any person for Medical Devices; Guidance for
and Food and Drug Administration and is not binding on FDA or the public. Industry and Food and Drug
Staff’’ to the Office of the Center You can use an alternative approach if Administration Staff; Availability
Director, Guidance and Policy it satisfies the requirements of the AGENCY: Food and Drug Administration,
Development, Center for Devices and applicable statutes and regulations. This HHS.
Radiological Health, Food and Drug guidance is not subject to Executive
Administration, 10903 New Hampshire ACTION: Notice of availability.
Order 12866.
Ave., Bldg. 66, Rm. 5431, Silver Spring, SUMMARY: The Food and Drug
MD 20993–0002. Send one self- III. Electronic Access Administration (FDA or Agency) is
addressed adhesive label to assist that Persons interested in obtaining a copy announcing the availability of the
office in processing your request. of the draft guidance may do so by guidance entitled ‘‘Use of Real-World
downloading an electronic copy from Evidence to Support Regulatory
sradovich on DSK3GMQ082PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Jismi Johnson, Center for Devices and the internet. A search capability for all Decision-Making for Medical Devices.’’
Radiological Health, Food and Drug Center for Devices and Radiological FDA is issuing this guidance to clarify
Administration, 10903 New Hampshire Health guidance documents is available how we evaluate real-world data to
at http://www.fda.gov/MedicalDevices/ determine whether it may be
Ave., Bldg. 66, Rm. 1524, Silver Spring,
DeviceRegulationandGuidance/ sufficiently relevant and reliable to
MD 20993–0002, 301–796–6424.
GuidanceDocuments/default.htm. generate the types of real-world
SUPPLEMENTARY INFORMATION: Guidance documents are also available evidence that can be used in FDA
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![41420 Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices
of sufficient relevance and reliability to the Paperwork Reduction Act of 1995 to the expert panel meeting, NTP will
address the specific regulatory decision (44 U.S.C. 3501–3520). The collections host four webinars that present other
being considered. of information in 21 CFR part 807, approaches to genomic dose-response
This guidance does not affect any subpart E, have been approved under modeling. The expert panel meeting and
Federal, State or local laws or OMB control number 0910–0120; the four webinar presentations leading up to
regulations or foreign laws or collections of information in 21 CFR the meeting are open to the public.
regulations that may otherwise be part 814, subparts A through E Registration is requested for both in-
applicable to the use or collection of (premarket approval), have been person meeting attendance and oral
RWE and that provide protections for approved under OMB control number comment; registration is required to
human subjects or patient privacy. This 0910–0231; the collections of access the meeting webcast. URLs for
guidance should be used to information in 21 CFR part 814, subpart live and archived pre-meeting webinars
complement, but not supersede, other H (humanitarian device exemption), will be available at https://
device-specific and good clinical have been approved under OMB control ntp.niehs.nih.gov/about/org/
practice guidance documents. FDA number 0910–0332; the collections of ntpexpertpanel/.
considered comments received on the information in 21 CFR part 812 DATES:
draft guidance that published in the (investigational device exemption) have Pre-Meeting Webinars: Dates are
Federal Register of July 27, 2016 (81 FR been approved under OMB control posted on the meeting Web site (https://
49228). FDA revised the guidance as number 0910–0078; the collections of ntp.niehs.nih.gov/about/org/
appropriate in response to the information in 21 CFR part 822 ntpexpertpanel/). Registration is not
comments. (postmarket surveillance) have been required to view the pre-meeting
approved under OMB control number webinars.
II. Significance of Guidance
0910–0449; the collections of Meeting: October 23–25, 2017; expert
This guidance is being issued information in 21 CFR 50.23 (exception panel meeting begins at 8:30 a.m.
consistent with FDA’s good guidance from general requirements for informed Eastern Daylight Time (EDT) each day
practices regulation (21 CFR 10.115). consent) have been approved under and continues until adjournment.
The guidance represents the current OMB control number 0910–0586; the Document Availability: Draft
thinking of FDA on use of real-world collections of information in 21 CFR document should be available by
evidence to support regulatory decision- part 54 (financial disclosure by clinical August 23, 2017, at https://
making for medical devices. It does not investigators) have been approved under ntp.niehs.nih.gov/about/org/
establish any rights for any person and OMB control number 0910–0396; the ntpexpertpanel/.
is not binding on FDA or the public. collections of information in 21 CFR Written Public Comment
You can use an alternative approach if 56.115 (institutional review boards Submissions: Deadline is October 13,
it satisfies the requirements of the records) have been approved under 2017.
applicable statutes and regulations. This OMB control number 0910–0130; and Registration for Oral Comments:
guidance is not subject to Executive the collections of information in 21 CFR Deadline is October 13, 2017.
Order 12866. parts 50 subpart B (informed consent of Registration for Meeting and/or to
III. Electronic Access human subjects) and 56 (institutional View Webcast: Deadline is October 25,
review boards) have been approved 2017. Registration to view the meeting
Persons interested in obtaining a copy under OMB control number 0910–0755. via webcast is required.
of the guidance may do so by The collections of information in the
downloading an electronic copy from ADDRESSES:
guidance ‘‘Requests for Feedback on Meeting Location: Rodbell
the internet. A search capability for all Medical Device Submissions: The Pre-
Center for Devices and Radiological Auditorium, Rall Building, NIEHS, 111
Submission Program and Meetings with T.W. Alexander Drive, Research
Health guidance documents is available Food and Drug Administration Staff’’
at https://www.fda.gov/MedicalDevices/ Triangle Park, NC 27709.
have been approved under OMB control Meeting Web site: The draft
DeviceRegulationandGuidance/ number 0910–0756.
GuidanceDocuments/default.htm. document, preliminary agenda,
Guidance documents are also available Dated: August 25, 2017. registration, pre-meeting webinars
at https://www.fda.gov/BiologicsBlood Leslie Kux, details, and other meeting materials will
Vaccines/GuidanceCompliance Associate Commissioner for Policy. be available at https://ntp.niehs.nih.gov/
RegulatoryInformation/default.htm or [FR Doc. 2017–18469 Filed 8–30–17; 8:45 am] about/org/ntpexpertpanel/.
Webcast: The URL for viewing the
https://www.regulations.gov. Persons BILLING CODE 4164–01–P
expert panel meeting webcast will be
unable to download an electronic copy
provided to those who register.
of ‘‘Use of Real-World Evidence to
Support Regulatory Decision-Making for DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT:
Medical Devices’’ may send an email HUMAN SERVICES Anna Stamatogiannakis, ICF, 2635
request to CDRH-Guidance@fda.hhs.gov Meridian Parkway, Suite 200, Durham,
National Institutes of Health NC, USA 27713. Phone: (919) 293–1652,
to receive an electronic copy of the
document. Please use the document Fax: (919) 293–1645, Email:
Peer Review of Draft NTP Approach to anna.stamatogiannakis@icf.com.
number 1500012 to identify the Genomic Dose-Response Modeling;
guidance you are requesting. SUPPLEMENTARY INFORMATION:
Availability of Documents; Request for
Background: NTP proposes to use the
sradovich on DSK3GMQ082PROD with NOTICES
IV. Paperwork Reduction Act of 1995 Comments; Notice of Expert Panel
approach embodied in the BMDExpress
Meeting
This guidance refers to previously software to perform gene and pathway-
approved collections of information SUMMARY: The National Toxicology level genomic dose-response modeling
found in FDA regulations and guidance. Program (NTP) announces an expert as part of Tox21 Phase 3 and in vivo
These collections of information are panel meeting and is obtaining screening level studies. NTP seeks
subject to review by the Office of comment on a proposed approach to external scientific input on its proposed
Management and Budget (OMB) under genomic dose-response modeling. Prior approach by an expert panel. NTP’s goal
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Document Created: 2017-09-23 10:08:14
Document Modified: 2017-09-23 10:08:14
| 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 of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on August 31, 2017. | |
| 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. | |
| FR Citation | 82 FR 41418 |
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