[Federal Register Volume 86, Number 3 (Wednesday, January 6, 2021)]
[Notices]
[Pages 547-549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29158]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-4048]


Safer Technologies Program for Medical Devices; 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 ``Safer Technologies 
Program for Medical Devices.'' This final guidance describes a new, 
voluntary program for certain medical devices and device-led 
combination products that are reasonably expected to significantly 
improve the safety of currently available treatments or diagnostics 
that target an underlying disease or condition associated with 
morbidities and mortalities less serious than those eligible for the 
Breakthrough Devices Program. Devices and device-led combination 
products are eligible for this program if they are subject to review 
under a premarket approval application (PMA), De Novo classification 
request (``De Novo request''), or premarket notification (510(k)), 
taking into account the specific eligibility factors described in this 
guidance. Consistent with the Agency's statutory mission to protect and 
promote public health, FDA believes that this ``Safer Technologies 
Program'' or ``STeP'' will help patients have more timely access to 
these medical devices and device-led combination products by expediting 
their development, assessment, and review, while preserving the 
statutory standards for premarket approval, De Novo marketing 
authorization, and 510(k) clearance.

DATES: The announcement of the guidance is published in the Federal 
Register on January 6, 2021.

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-2019-D-4048 for ``Safer Technologies Program for Medical Devices.'' 
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, 240-402-7500.
     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.govinfo.gov/content/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, 240-402-7500.
    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 
``Safer Technologies Program for Medical Devices'' 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 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: Christina Savisaar, Center for Devices

[[Page 548]]

and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G221, Silver Spring, MD 20993-0002, 301-
796-6404 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 is introducing a new, voluntary program for certain medical 
devices and device-led combination products that are reasonably 
expected to significantly improve the safety of currently available 
treatments or diagnostics that target an underlying disease or 
condition associated with morbidities and mortalities less serious than 
those eligible for the Breakthrough Devices Program; for example, this 
may include devices treating or diagnosing non-life-threatening or 
reasonably reversible conditions. Devices and device-led combination 
products are eligible for this program if they are subject to review 
under a premarket approval application (PMA), De Novo classification 
request (``De Novo request''), or premarket notification (510(k)), 
taking into account the specific eligibility factors described in this 
guidance. Consistent with the Agency's statutory mission to protect and 
promote public health, FDA believes that this ``Safer Technologies 
Program'' or ``STeP'' will help patients have more timely access to 
these medical devices and device-led combination products by expediting 
their development, assessment, and review, while preserving the 
statutory standards for premarket approval, De Novo marketing 
authorization, and 510(k) clearance. FDA has modeled STeP on the key 
principles and features of FDA's Breakthrough Devices Program as 
mandated in section 515B of the Federal Food, Drug and Cosmetic Act (21 
U.S.C. 360e-3) and further described in the FDA guidance document 
entitled ``Breakthrough Devices Program'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program). As resources permit, FDA intends for STeP to 
incorporate similar features offered under the Breakthrough Devices 
Program, such as interactive and timely communications, early 
engagement on Data Development Plans, sprint discussions, and senior 
management engagement.
    FDA recognizes and anticipates that the Agency may need up to 60 
days to perform activities to operationalize STeP following issuance of 
the final guidance. FDA does not intend to accept requests for 
inclusion in STeP within this time period.
    A notice of availability of the draft guidance appeared in the 
Federal Register of September 19, 2019 (84 FR 49306). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including revisions related to program scope, such as 
providing additional examples of devices that may be eligible for the 
program, and revisions to clarify the review time clock. The guidance 
was also revised to further emphasize that participation in STeP does 
not change or impact the statutory requirements for marketing 
authorization applicable to a medical device nor does it affect the 
application of least burdensome policies and approaches.
    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 Safer Technologies Program 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.

II. 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to download an electronic 
copy of ``Safer Technologies Program for Medical Devices'' may send an 
email request to [email protected] to receive an electronic 
copy of the document. Please use the document number 19001 and complete 
title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. 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 or guidance               Topic                 No.
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807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
812............................  Investigational Device        0910-0078
                                  Exemption.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
``De Novo Classification         De Novo classification        0910-0844
 Process (Evaluation of           process.
 Automatic Class III
 Designation)''.
``Requests for Feedback and      Q-submissions..........       0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
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[[Page 549]]

    Dated: December 29, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-29158 Filed 1-5-21; 8:45 am]
BILLING CODE 4164-01-P