
[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)]
[Notices]
[Pages 35216-35218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-15891]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4301]


Fostering Medical Innovation: A Plan for Digital Health Devices; 
Software Precertification Pilot Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA, the Agency, or we) 
Center for Devices and Radiological Health (CDRH or Center) is 
announcing its Software Precertification Pilot Program. The program 
aims to evaluate a new approach toward software products, including a 
precertification program for the assessment of companies that perform 
high-quality software design and testing. This voluntary pilot program 
is part of FDA's ongoing efforts to develop pragmatic approaches to 
balance benefits and risks of digital health products. FDA intends to 
develop a precertification program that could replace the need for a 
premarket submission in some cases and allow for decreased submission 
content and/or faster review of marketing applications for software 
products in other cases. During the pilot program, FDA customers, 
including pilot participants, will have the opportunity to provide 
input on the development of the precertification program.

DATES: FDA is seeking participation in the voluntary Software 
Precertification pilot program beginning August 1, 2017. See the 
``Participation'' section for instructions on how to submit a request 
to participate. The voluntary Software Precertification pilot program 
will select up to nine participants who best match the selection 
criteria. This pilot program will begin September 1, 2017.

ADDRESSES: You may submit comments 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-2017-N-4301 for ``Fostering Medical Innovation: A Plan for Digital 
Health Devices; Software Precertification Pilot Program.'' 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.

FOR FURTHER INFORMATION CONTACT: Bakul Patel, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5458, Silver Spring, MD 20993, 301-796-5528, 
Bakul.Patel@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA recognizes that an efficient, risk-based approach to regulating 
digital health technology will foster innovation of digital health 
products. FDA's traditional approach to moderate and higher risk 
hardware-based medical devices is not well suited for the faster 
iterative design, development, and type of validation used for software 
products. An agile paradigm is necessary to accommodate the faster rate 
of development and innovation of software devices as compared to other 
types of devices. Traditional implementation of the premarket 
requirements may impede or delay patient access to critical evolutions 
of software technology, particularly those presenting a lower risk to 
patients. To evaluate a new approach toward software, FDA is launching 
a pilot of a precertification program for the assessment of companies 
that perform high-quality software design and testing. The Software 
Precertification (Pre-Cert) pilot program is part of FDA's ongoing 
efforts

[[Page 35217]]

to develop pragmatic approaches within its existing authorities to 
optimally foster the development of high-quality, safe and effective 
digital health products while assuring timely patient access. FDA has 
previously discussed the idea of a precertification program in various 
forums and invites further input from all stakeholders throughout this 
pilot. FDA intends to establish a process for company precertification 
that could replace the need for a premarket submission for certain 
products or allow for decreased submission content and/or faster review 
of marketing submissions for other products. CDRH plans to select its 
first participants and initiate the voluntary Software Pre-Cert pilot 
program focusing on receiving input on the activities and criteria 
critical to streamlining premarket review of software products by 
September 1, 2017.
    FDA is issuing its Digital Health Innovation Action Plan.\1\ The 
Action Plan presents FDA's vision for the regulation of digital health 
technologies that are medical devices and the actions FDA intends to 
pursue to provide greater clarity regarding what types of digital 
health technology are subject to regulation. In the Action Plan, FDA 
describes a forward-leaning approach to ensure that we will implement 
the right policies and regulatory tools. The Software Pre-Cert pilot 
program is one component of FDA's comprehensive approach to digital 
health medical devices described in the Action Plan. FDA welcomes 
comments on the policies, pathways, and regulatory tools the Agency 
should consider in designing a new paradigm for overseeing digital 
health medical devices. (See information on how to submit comments to 
the public docket in the ADDRESSES section.)
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    \1\ Available at https://www.fda.gov/MedicalDevices/DigitalHealth/UCM567265.
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    The Software Pre-Cert pilot will help inform the development of the 
Pre-Cert program for software developers, including what criteria can 
be used to assess whether a company consistently and reliably engages 
in high-quality software design and testing (validation) and ongoing 
maintenance of its software products. FDA and companies participating 
in the pilot program will explore the use of external software 
development standards to reduce premarket software documentation 
burden. Precertified companies that have demonstrated a culture of 
quality and organizational excellence could bring certain types of 
digital health products to market without FDA premarket review or after 
a streamlined, less-burdensome FDA premarket review. The criteria 
developed and evaluated for precertification during the pilot program 
may also be used to inform the establishment of a third-party 
certification program, in which third parties may facilitate the 
precertification of companies, and will enable greater patient access 
to digital health technologies and will allow the Agency to devote more 
resources to the evaluation of higher risk technologies/products.
    Companies are eligible to participate in this voluntary Software 
Pre-Cert pilot program based on the criteria listed in Section A. 
Participation. FDA will select up to nine participants, who best match 
the selection criteria and who reflect the broad spectrum of software 
developers (e.g., both small and large software development firms). FDA 
intends to include companies that develop a range of products (both low 
and high risk) to learn how to apply the Software Pre-Cert program to 
different product types. FDA also intends to include companies that are 
not considered to be traditional medical device manufacturers, but who 
intend to make digital health technology.
    The purpose of the Software Pre-Cert pilot is to leverage customer 
input to develop a program that can help reduce the time and cost of 
market entry for software developers that FDA determines reliably 
manufacture high-quality, safe and effective digital health devices. 
This voluntary pilot program does not represent a new requirement; 
instead, it is an opportunity to help FDA develop an innovative 
approach for digital health technology.

A. Participation

    Companies that may be eligible to participate in this voluntary 
Software Pre-Cert pilot program are limited to those firms who follow 
the procedures set out in Section B and also meet the following 
selection qualities that follow.
    1. The company must be developing or planning to develop a software 
product that meets the definition of a device in section 201(h) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h)).
    2. The company has an existing track record in developing, testing, 
and maintaining software products demonstrating a culture of quality 
and organizational excellence measured and tracked by Key Performance 
Indicators (KPIs) or other similar measures.
    3. While participating in the pilot, the company must agree to:
    a. Provide access to measures described in selection quality number 
2, listed previously (KPIs or similar measures).
    b. Collect real-world postmarket performance data and provide it to 
FDA.
    c. Be available for real-time consultations with FDA.
    d. Be available for site visits from FDA officials.
    e. Provide information about the firm's quality management system.

B. Procedures

    To be considered for the voluntary Software Pre-Cert pilot program, 
a company should submit a statement of interest for participation to 
FDAPre-CertPilot@fda.hhs.gov. The statement of interest should include 
agreement to the selection qualities listed in Section A. 
Participation.
    The following captures the proposed process for the voluntary 
Software Pre-Cert pilot program:
    1. FDA will collect statements of interest for participation in the 
pilot program beginning August 1, 2017.
    2. FDA will evaluate the statements of interest for participation 
and select no more than nine participants, who best meet the selection 
criteria and who reflect the broad spectrum of software developers, 
including companies that develop a range of products (both low and high 
risk). FDA will work with the selected participants to develop criteria 
for precertification and the types of information that should be 
reviewed during the precertification process or postmarket, rather than 
during the review of a premarket submission.
    a. Depending on the stage of development of the company's software 
product, FDA will work interactively with the participating company 
through the Q-submission process, including via Pre-Submissions, 
Informational Meetings, Submission Issue Meetings, etc. (Ref. 1).
    3. Enrollment in the pilot program will be ongoing throughout the 
duration of the program. FDA will apply lessons learned from the 
initial participants in the pilot program to refine the 
precertification program in collaboration with participants.
    During this voluntary Software Pre-Cert pilot program, CDRH staff 
intends to be available to answer questions or concerns that may arise. 
The voluntary Software Pre-Cert pilot program participants will be 
asked to comment on and discuss their experiences with the Software 
Pre-Cert pilot process.

II. Beginning Date of the Software Pre-Cert Pilot Program

    FDA intends to accept requests for participation in the voluntary 
Software Pre-Cert pilot program beginning August 1, 2017. This pilot 
program will begin September 1, 2017.

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III. Paperwork Reduction Act of 1995

    This notice refers to previously approved collections of 
information found in FDA regulations. 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 part 807, subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 814, subparts A through E have been approved 
under OMB control number 0910-0231; the collections of information in 
21 CFR part 820 have been approved under OMB control number 0910-0073; 
and the collections of information in ``Requests for Feedback on 
Medical Device Submissions: The Pre-Submission Program and Meetings 
with Food and Drug Administration Staff'' have been approved under OMB 
control number 0910-0756.

IV. Reference

    The following reference is on display in the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://www.regulations.gov. FDA has 
verified the Web site address, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. ``Requests for Feedback on Medical Device Submissions: The Pre-
Submission Program and Meetings with Food and Drug Administration 
Staff; Guidance for Industry and Food and Drug Administration 
Staff,'' February 2014, available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm311176.pdf.


    Dated: July 24, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-15891 Filed 7-27-17; 8:45 am]
 BILLING CODE 4164-01-P


