[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

[[Page 1159]]

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]
 BILLING CODE 4164-01-P