[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Pages 49306-49308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20322]


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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Safer Technologies Program for Medical Devices; Draft Guidance 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the availability of the draft guidance entitled ``Safer Technologies 
Program for Medical Devices.'' This draft guidance describes a new, 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)). 
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. This draft guidance is not final nor is it in effect 
at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by November 18, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the

[[Page 49307]]

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.
     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 draft 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 to the Office 
of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), 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: Maureen Dreher, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1545, Silver Spring, MD 20993-0002, 301-796-2505; 
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)). 
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''.\1\ 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, prioritized review, and senior 
management engagement.
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    \1\ https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program.
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    FDA recognizes and anticipates that the Agency may need up to 60 
days to perform activities to operationalize this STeP following 
issuance of the final guidance. FDA does not intend to accept requests 
for inclusion in STeP within this time period.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115).

[[Page 49308]]

The draft guidance, when finalized, will represent 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. This guidance 
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft 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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. 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 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft 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 or guidance               Topic               No.
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807, subpart E....................  Premarket                  0910-0120
                                     Notification.
814, subparts A through E.........  Premarket Approval..       0910-0231
812...............................  Investigational            0910-0078
                                     Device Exemption.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
``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''.
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    Dated: September 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20322 Filed 9-18-19; 8:45 am]
 BILLING CODE 4164-01-P