[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Notices]
[Pages 57988-57990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26457]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Fostering Digital Health Innovation: Developing the Software 
Precertification Program; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing the following public workshop entitled ``Fostering Digital 
Health Innovation: Developing the Software Precertification Program.'' 
The purpose of the public workshop is to discuss the progress of the 
pilot precertification program and to seek input on the ongoing 
development of the Software Precertification Program. In its Digital 
Health Innovation Action Plan and as part of the Medical Device User 
Fee Amendments, FDA has committed to explore opportunities to establish 
streamlined regulatory pathways tailored for digital health 
technologies that take into account real world evidence while 
incorporating principles established through international 
harmonization.

DATES: The public workshop will be held on January 30 to 31, 2018, from 
8:30 a.m. to 5 p.m. Submit either electronic or written comments on 
this public workshop by June 29, 2018. See the SUPPLEMENTARY 
INFORMATION section for registration date and information.

ADDRESSES: The public workshop will be held at Ruth L. Kirschstein 
Auditorium, Natcher Conference Center, Bldg. 45, National Institutes of 
Health (NIH) Campus, 9000 Rockville Pike, Bethesda, MD 20892. The 
entrance for the public workshop participants (non-NIH employees) is 
through the NIH Gateway Center located adjacent to the Medical Center 
Metro, where routine security check procedures will be performed. 
Please visit the following Web site for NIH campus location, parking, 
security, and travel information: http://www.nih.gov/about/visitor/index.htm. Please visit the following Web site for information on the 
Natcher Conference Center: http://www.genome.gov/11007522.
    You may submit comments as follows. Please note that late, untimely 
filed comments will not be considered. Electronic comments must be 
submitted on or before June 29, 2018, at the https://www.regulations.gov electronic filing system. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

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

[[Page 57989]]

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 Digital Health Innovation: Developing 
the Software Precertification Program; Public Workshop; Request for 
Comments.'' Received comments, those filed in a timely manner (see 
ADDRESSES), 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, Food and Drug 
Administration, Center for Devices and Radiological Health, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5458, Silver Spring, MD 20993, 301-796-
5528, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    As part of the FDA Reauthorization Act of 2017 (Pub. L. 115-52), 
which reauthorizes the Medical Device User Fee Amendments for fiscal 
years 2018 through 2022, FDA has committed to explore opportunities to 
establish streamlined regulatory pathways tailored for digital health 
technologies that consider real world evidence while incorporating 
principles established through international harmonization. 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-based medical 
technologies.
    FDA issued a Digital Health Innovation Action Plan on July 27, 
2017, in order to outline its efforts to develop pragmatic approaches 
to balance benefits and risks of digital health products (Ref. 1). In 
the Federal Register of July 28, 2017, FDA announced its Software 
Precertification (Pre-Cert) Pilot Program (82 FR 35216). The voluntary 
pilot 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. 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. The pilot program began in September 2017. 
This public workshop provides an opportunity for FDA customers to 
provide input on the development of the precertification program.

II. Topics for Discussion at the Public Workshop

    During the public workshop, speakers and participants will discuss 
a range of issues related to the Software Pre-Cert program and the 
development of novel premarket approval/clearance pathways for digital 
health products. Discussion topics include:
     Criteria and measures to assess whether a company 
consistently and reliably engages in high-quality software design and 
testing (validation) and ongoing maintenance of its software products.
    [cir] Appropriate ``Key Performance Indicators'' that are 
independent of organization size, deployment strategies, or computing 
platforms.
     Levels of precertification and how those levels correlate 
to the digital health product's risk.
     Other aspects and topics related to pre-certifying a 
company including methods and mechanisms for a company to maintain 
precertification status.
     Types of digital health products that should be marketed 
based on the levels of precertification without FDA premarket review or 
after a streamlined, less-burdensome FDA premarket review.
     Considerations for streamlined premarket review and 
postmarket data collection and analysis.

III. Participating in the Public Workshop

    Registration: To register for the public workshop, please visit 
FDA's Medical Devices News & Events--Workshops & Conferences calendar 
(https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm) and select this event from the list of items provided. 
Please provide complete contact information for each attendee, 
including name, title, affiliation, address, email, and telephone 
number.

[[Page 57990]]

    Registration is free and based on space availability, with priority 
given to early registrants. Persons interested in attending this public 
workshop must register by January 18, 2018, 4 p.m. Eastern Time. Early 
registration is recommended because seating is limited; therefore, FDA 
may limit the number of participants from each organization. 
Registrants will receive confirmation when they have been accepted. If 
time and space permit, onsite registration on the day of the public 
workshop will be provided beginning at 7:30 a.m. We will let 
registrants know if registration closes before the day of the public 
workshop.
    If you need special accommodations due to a disability, please 
contact Susan Monahan, Center for Devices and Radiological Health, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5231, 
Silver Spring, MD 20993-0002, 301-796-5661 or email: 
[email protected], no later than January 16, 2018.
    Requests for Oral Presentations: During online registration, you 
may indicate if you wish to present during a public comment session and 
which topic(s) you wish to address. We will do our best to accommodate 
requests to make public comments and requests to participate in the 
focused sessions. Individuals and organizations with common interests 
are urged to consolidate or coordinate their presentations, and request 
time for a joint presentation, or submit requests for designated 
representatives to participate in the focused sessions. Following the 
close of registration, we will determine the amount of time allotted to 
each presenter and the approximate time each oral presentation is to 
begin, and will select and notify participants by January 19, 2018. All 
requests to make oral presentations must be received by the close of 
registration on January 18, 2018, 4 p.m. If selected for presentation, 
any presentation materials must be emailed to Maggie Fu at 
[email protected] no later than January 25, 2018. No commercial or 
promotional material will be permitted to be presented or distributed 
at the public workshop.
    Streaming Webcast of the Public Workshop: This public workshop will 
also be webcast. The webcast link will be available on the registration 
Web page after January 23, 2018. Please visit FDA's Medical Devices 
News & Events--Workshops & Conferences calendar (https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm) and select 
this event from the list of items provided. Organizations are requested 
to register all participants, but to view using one connection per 
location.
    If you have never attended a Connect Pro event before, test your 
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, 
visit http://www.adobe.com/go/connectpro_overview. FDA has verified the 
Web site addresses in this document, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.
    Transcripts: Please be advised that as soon as a transcript of the 
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff 
(see ADDRESSES). A link to the transcript will also be available on the 
Internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.

IV. Reference

    The following reference is on display at 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 addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

1. FDA's Digital Health Innovation Action Plan issued on July 27, 
2017 available at: https://www.fda.gov/MedicalDevices/DigitalHealth/UCM567265.

    Dated: December 4, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26457 Filed 12-7-17; 8:45 am]
 BILLING CODE 4164-01-P


