[Federal Register Volume 84, Number 169 (Friday, August 30, 2019)]
[Notices]
[Pages 45771-45773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-18802]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-3130]
Consideration of Uncertainty in Making Benefit-Risk
Determinations in Medical Device Premarket Approvals, De Novo
Classifications, and Humanitarian Device Exemptions; 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 a final guidance entitled ``Consideration of
Uncertainty in Making Benefit-Risk Determinations in Medical Device
Premarket Approvals, De Novo Classifications, and Humanitarian Device
Exemptions.'' This guidance document describes FDA's current approach
to considering uncertainty in making benefit-risk determinations to
support certain FDA premarket decisions for medical devices--premarket
approval applications (PMAs), De Novo requests, and humanitarian device
exemption applications. This guidance document elaborates on the
consideration of uncertainty as part of our overarching approach to a
benefit-risk based framework that is intended to assure greater
predictability, consistency, and efficiency through the application of
least burdensome principles. This guidance also provides examples of
how the principles for considering uncertainty could be applied in the
context of clinical evidence and circumstances where greater
uncertainty could be appropriate in premarket decisions, balanced by
postmarket controls--PMAs for Breakthrough Devices and PMAs for devices
for small patient populations.
DATES: The announcement of the guidance is published in the Federal
Register on August 30, 2019.
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-2018-D-3130 for ``Consideration of Uncertainty in Making Benefit-
Risk Determinations in Medical Device Premarket Approvals, De Novo
Classifications, and Humanitarian Device Exemptions; Guidance for
Industry and Food and Drug Administration Staff; Availability.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at
[[Page 45772]]
https://www.regulations.gov or at the Dockets Management Staff 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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
``Consideration of Uncertainty in Making Benefit-Risk Determinations in
Medical Device Premarket Approvals, De Novo Classifications, and
Humanitarian Device Exemptions'' to the Office of Policy, 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: Sonja Fulmer, Office of Policy, Center
for Devices and Radiological Health, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66, Rm. 5451, Silver Spring, MD 20993-
0002, 240-402-5979.
SUPPLEMENTARY INFORMATION:
I. Background
The 1976 Medical Device Amendments (Pub. L. 94-295) to the Federal
Food, Drug, and Cosmetic Act (FD&C Act) established a risk-based
framework for the regulation of medical devices. The law established a
three-tiered risk classification system based on the risk posed to
patients should the device fail to perform as intended. Under this
system, devices that pose greater risks to patients are subject to more
regulatory controls and requirements. Generally, for any regulatory
decision, there exists some uncertainty around benefits and risks. The
Agency generally provides marketing authorization for a device when it
meets the applicable standards, including that its benefits outweigh
its risks.
In 2015, following pilots conducted over 4 years, FDA established
the Expedited Access Pathway (EAP) Program as a voluntary program for
certain medical devices that address an unmet need in the treatment or
diagnosis of life-threatening or irreversibly debilitating diseases or
conditions. Under this program, an eligible device subject to a PMA
could be approved with greater uncertainty about the product's benefits
and risks, provided that, among other requirements, the data still
support a reasonable assurance of safety and effectiveness, including
that the probable benefits of the device outweigh its risks for a
patient population with unmet medical needs. For devices subject to
PMA, the Agency has the authority to impose, when warranted, postmarket
requirements, including post-approval studies and postmarket
surveillance, as a condition of approval, which could be used to
address this greater uncertainty.\1\ In the Breakthrough Device
provisions of the FD&C Act, as added by the 21st Century Cures Act
(Cures Act) and amended by the FDA Reauthorization Act of 2017 (FDARA),
Congress codified and expanded this program to include devices reviewed
through a 510(k) notification.\2\
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\1\ See sections 513(a)(3)(C), 515(c)(5)(C), 515(d)(1)(B)(ii),
and 515B(e)(2)(C) of the FD&C Act (21 U.S.C. 360c(a)(3)(C),
360e(c)(5)(C), 360e(d)(1)(B)(ii), and 360e-3(e)(2)(C)); 21 CFR
814.82.
\2\ See section 515B of the FD&C Act, as created by section 3051
of the Cures Act (Pub. L. 114-255) and amended by section 901 of
FDARA (Pub. L. 115-52).
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This guidance provides further information on how FDA considers
uncertainty in benefit-risk determinations for PMAs, De Novo requests,
and Humanitarian Device Exemption applications. FDA considered comments
received on the draft guidance that appeared in the Federal Register of
September 6, 2018 (83 FR 45247). 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 Consideration of Uncertainty in Making
Benefit-Risk Determinations in Medical Device Premarket Approvals, De
Novo Classifications, and Humanitarian Device Exemptions. 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. This
guidance document is also available at https://www.regulations.gov or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to
download an electronic copy of ``Consideration of Uncertainty in Making
Benefit-Risk Determinations in Medical Device Premarket Approvals, De
Novo Classifications, and Humanitarian Device Exemptions'' may send an
email request to [email protected] to receive an electronic
copy of the document. Please use the document number 17039 to identify
the guidance you are requesting.
[[Page 45773]]
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information. 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
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:
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OMB control
21 CFR part; guidance; or FDA form Topic No.
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814, subparts A through E......... Premarket approval.. 0910-0231
814, subpart H.................... Humanitarian Device 0910-0332
Exemption.
``De Novo Classification Process De Novo 0910-0844
(Evaluation of Automatic Class classification
III Designation)''. process.
``Requests for Feedback on Medical Q-submissions....... 0910-0756
Device Submissions: The Pre-
Submission Program and Meetings
with Food and Drug Administration
Staff``.
801 and 809....................... Medical Device 0910-0485
Labeling
Regulations.
822............................... Postmarket 0910-0449
Surveillance of
Medical Devices.
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Dated: August 27, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-18802 Filed 8-29-19; 8:45 am]
BILLING CODE 4164-01-P