[Federal Register Volume 84, Number 22 (Friday, February 1, 2019)]
[Notices]
[Pages 1157-1159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00568]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-1387]
Safety and Performance Based Pathway; 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 ``Safety and Performance
Based Pathway,'' which was previously issued in draft version entitled
``Expansion of the Abbreviated 510(k) Program: Demonstrating
Substantial Equivalence Through Performance Criteria.'' This final
[[Page 1158]]
guidance provides FDA's current thinking on using performance criteria
to demonstrate substantial equivalence for premarket notification
(510(k)) submissions. The intent of the final guidance is to describe
an optional program for certain well understood device types, where a
submitter could demonstrate that a new device meets FDA-identified
performance criteria instead of directly comparing the performance of
the new device to a specific, submitter-identified predicate device as
part of a demonstration of substantial equivalence.
DATES: The announcement of the guidance is published in the Federal
Register on February 1, 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-1387 for ``Safety and Performance Based Pathway; 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 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
``Safety and Performance Based Pathway'' 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 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: Sonja Fulmer, 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;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has explained and clarified, through the guidance entitled
``The 510(k) Program: Evaluating Substantial Equivalence in Premarket
Notifications [510(k)],'' \1\ how it makes substantial equivalence
decisions under section 513(i)(1)(A) of the Federal, Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 360c(i)(1)(A)). Substantial
equivalence is rooted in comparisons between new devices and predicate
devices. However, the FD&C Act does not preclude FDA from using
performance criteria to facilitate this comparison. If a legally
marketed device performs at certain levels relevant to its safety and
effectiveness, and a new device meets those levels of performance for
the same characteristics, FDA could find the new device as safe and
effective as the legally marketed device. Instead of reviewing data
from direct comparison testing between the two devices, FDA could
support a finding of substantial equivalence with data demonstrating
the new device meets the level of performance of an appropriate
predicate device(s). Under the approach expanded in this guidance, a
submitter could
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satisfy the requirement to compare its device with a legally marketed
device by, among other things, independently demonstrating conformance
to all performance criteria necessary to support a finding of
substantial equivalence for a device type established in FDA guidance,
rather than using direct predicate comparison testing for some of the
performance characteristics.
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\1\ Available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284443.
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Use of objective performance criteria developed for this approach
may promote predictability and consistency in the review of 510(k)
submissions, thereby reducing burdens on the Agency and possibly review
times on individual submissions. At the same time, this approach
satisfies the statutory standard for demonstrating substantial
equivalence. The reviews of Safety and Performance Based Pathway 510(k)
submissions remain subject to the same timeframes as Traditional 510(k)
submissions, but FDA anticipates that faster review timeframes may be
possible for the Safety and Performance Based Pathway 510(k)
submissions. As a result, this pathway is intended to promote the
public health by helping patients gain more timely access to new
medical devices that are high quality, safe, and effective. Moreover,
as FDA stated in its April 2018 Medical Device Safety Action Plan,\2\
this approach would provide an opportunity for device developers to
demonstrate that their product meets these modern performance criteria
as well as the ability to do so in a more straightforward and efficient
manner than under the traditional 510(k) Pathway. Through this more
transparent approach, FDA may drive greater market competition to
develop safer devices. Manufacturers would be able to demonstrate that
their products meet established performance criteria (including those
related to safety), and thus, may be able to more readily demonstrate
that their products perform equivalent to or better than other devices
on the market (including that they are safer).
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\2\ ``Medical Device Safety Action Plan: Protecting Patients,
Promoting Public Health,'' April 2018, available at https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM604690.pdf.
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FDA considered comments received on the draft guidance entitled
``Expansion of the Abbreviated 510(k) Program: Demonstrating
Substantial Equivalence Through Performance Criteria'' that appeared in
the Federal Register of April 12, 2018 (83 FR 15847). FDA has changed
the name of this draft guidance to the ``Safety and Performance Based
Pathway'' and revised it as appropriate in response to the comments
received. Among others, FDA received comments requesting additional
clarity on the device types that will be appropriate for the Safety and
Performance Based Pathway and how the performance criteria will be
developed. FDA intends to maintain a list of device types appropriate
for the Safety and Performance Based Pathway on the FDA website.
Additionally, industry and other stakeholders may suggest device types
for which FDA should consider establishing performance criteria, by for
example, identifying products for which there are comprehensive FDA-
recognized consensus standards. FDA also welcomes evidence-based
suggestions on what the performance criteria should be for such device
types. FDA intends to develop performance criteria for appropriate
device types through guidance in accordance with the good guidance
practices regulation (Sec. 10.115), which includes an opportunity for
FDA to receive input from stakeholders.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (Sec. 10.115). The guidance represents the
current thinking of FDA on the ``Safety and Performance Based
Pathway.'' 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 ``Safety and Performance Based Pathway''
may send an email request to [email protected] to receive an
electronic copy of the document. Please use the document number 17046
to identify the guidance you are requesting.
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 21
CFR 807, subpart E have been approved under OMB control number 0910-
0120.
Dated: January 15, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00568 Filed 1-31-19; 8:45 am]
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