82 FR 57988 - Fostering Digital Health Innovation: Developing the Software Precertification Program; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 235 (December 8, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 235 (December 8, 2017)
| Page Range | 57988-57990 | |
| FR Document | 2017-26457 |
[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)] [Notices] [Pages 57988-57990] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26457] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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.thefederalregister.org/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
![57988 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices
diseases or other conditions (often https://www.regulations.gov. Persons purpose of the public workshop is to
referred to as clinical decision support unable to download an electronic copy discuss the progress of the pilot
software). Similar software functions of ‘‘Clinical and Patient Decision precertification program and to seek
may be intended for use by patients. Support Software’’ may send an email input on the ongoing development of
This draft guidance provides clarity on request to CDRH-Guidance@fda.hhs.gov the Software Precertification Program.
the scope of FDA’s oversight of: (1) to receive an electronic copy of the In its Digital Health Innovation Action
Clinical decision support software document. Please use the document Plan and as part of the Medical Device
intended for healthcare professionals, number 1400062 to identify the User Fee Amendments, FDA has
and (2) patient decision support guidance you are requesting. committed to explore opportunities to
software intended for patients and establish streamlined regulatory
IV. Paperwork Reduction Act of 1995
caregivers who are not healthcare pathways tailored for digital health
professionals. This guidance refers to previously technologies that take into account real
FDA recognizes that the term ‘‘clinical approved collections of information world evidence while incorporating
decision support’’ or ‘‘CDS’’ is used found in FDA regulations. These principles established through
broadly and in different ways, collections of information are subject to international harmonization.
depending on the context. This draft review by the Office of Management and
DATES: The public workshop will be
guidance defines ‘‘CDS’’ in the context Budget (OMB) under the Paperwork
held on January 30 to 31, 2018, from
of and using language from section Reduction Act of 1995 (44 U.S.C. 3501–
8:30 a.m. to 5 p.m. Submit either
3060(a) of the 21st Century Cures Act 3520). The collections of information in
electronic or written comments on this
(Cures Act), which amended section 520 21 CFR part 812 have been approved
under OMB control number 0910–0078; public workshop by June 29, 2018. See
of the FD&C Act (21 U.S.C. 360j) and the SUPPLEMENTARY INFORMATION section
excludes certain software functions the collections of information in 21 CFR
part 807, subpart E, have been approved for registration date and information.
from the device definition. The purpose
of this guidance is to identify the types under OMB control number 0910–0120; ADDRESSES: The public workshop will
of decision support software the collections of information in 21 CFR be held at Ruth L. Kirschstein
functionalities that: (1) Do not meet the part 814, subparts A through E, have Auditorium, Natcher Conference Center,
definition of a device, in light of the been approved under OMB control Bldg. 45, National Institutes of Health
Cures Act; (2) may meet the definition number 0910–0231; the collections of (NIH) Campus, 9000 Rockville Pike,
of a device but for which FDA does not information in 21 CFR part 814, subpart Bethesda, MD 20892. The entrance for
intend to enforce compliance with H have been approved under OMB the public workshop participants (non-
applicable requirements of the FD&C control number 0910–0332; the NIH employees) is through the NIH
Act, including, but not limited to, collections of information in 21 CFR Gateway Center located adjacent to the
premarket clearance and premarket part 601 have been approved under Medical Center Metro, where routine
approval requirements; and (3) FDA OMB control number 0910–0338; the security check procedures will be
intends to focus its regulatory oversight collections of information in 21 CFR performed. Please visit the following
on. part 314 have been approved under Web site for NIH campus location,
OMB control number 0910–0001; and parking, security, and travel
II. Significance of Guidance the collections of information in 21 CFR information: http://www.nih.gov/about/
This draft guidance is being issued parts 801 and 809 have been approved visitor/index.htm. Please visit the
consistent with FDA’s good guidance under OMB control number 0910–0485. following Web site for information on
practices regulation (21 CFR 10.115). Dated: December 4, 2017.
the Natcher Conference Center: http://
The draft guidance, when finalized, will www.genome.gov/11007522.
Leslie Kux,
represent the current thinking of FDA You may submit comments as
Associate Commissioner for Policy. follows. Please note that late, untimely
on ‘‘Clinical and Patient Decision
[FR Doc. 2017–26439 Filed 12–7–17; 8:45 am] filed comments will not be considered.
Support Software.’’ It does not establish
any rights for any person and is not BILLING CODE 4164–01–P Electronic comments must be submitted
binding on FDA or the public. You can on or before June 29, 2018, at the
use an alternative approach if it satisfies https://www.regulations.gov electronic
DEPARTMENT OF HEALTH AND filing system. Comments received by
the requirements of the applicable
HUMAN SERVICES mail/hand delivery/courier (for written/
statutes and regulations. This guidance
is not subject to Executive Order 12866. Food and Drug Administration paper submissions) will be considered
timely if they are postmarked or the
III. Electronic Access [Docket No. FDA–2017–N–4301] delivery service acceptance receipt is on
Persons interested in obtaining a copy or before that date.
of the draft guidance may do so by Fostering Digital Health Innovation:
downloading an electronic copy from Developing the Software Electronic Submissions
the internet. A search capability for all Precertification Program; Public Submit electronic comments in the
Center for Devices and Radiological Workshop; Request for Comments following way:
Health guidance documents is available AGENCY: Food and Drug Administration, • Federal eRulemaking Portal:
at https://www.fda.gov/MedicalDevices/ HHS. https://www.regulations.gov. Follow the
DeviceRegulationandGuidance/ ACTION: Notice of public workshop; instructions for submitting comments.
Guidance Documents/default.htm. Comments submitted electronically,
sradovich on DSK3GMQ082PROD with NOTICES
request for comments.
Guidance documents are also available including attachments, to https://
at https://www.fda.gov/BiologicsBlood SUMMARY: The Food and Drug www.regulations.gov will be posted to
Vaccines/Guidance Administration (FDA, the Agency, or the docket unchanged. Because your
ComplianceRegulatoryInformation/ we) is announcing the following public comment will be made public, you are
default.htm or https://www.fda.gov/ workshop entitled ‘‘Fostering Digital solely responsible for ensuring that your
Drugs/GuidanceComplianceRegulatory Health Innovation: Developing the comment does not include any
Information/Guidances/default.htm or Software Precertification Program.’’ The confidential information that you or a
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![57990 Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Notices
Registration is free and based on requested to register all participants, but ACTION: Notice; establishment of a
space availability, with priority given to to view using one connection per public docket; request for comments.
early registrants. Persons interested in location.
attending this public workshop must SUMMARY: The Food and Drug
If you have never attended a Connect
register by January 18, 2018, 4 p.m. Administration (FDA) is announcing an
Pro event before, test your connection at
Eastern Time. Early registration is opportunity for public comment on the
https://collaboration.fda.gov/common/
recommended because seating is statement of work to assess current
help/en/support/meeting_test.htm. To
limited; therefore, FDA may limit the practices of FDA and sponsors in
get a quick overview of the Connect Pro
number of participants from each communicating during investigational
program, visit http://www.adobe.com/
organization. Registrants will receive new drug (IND) development and
go/connectpro_overview. FDA has
confirmation when they have been identify best practices and areas of
verified the Web site addresses in this
accepted. If time and space permit, improvement. The independent
document, as of the date this document assessment is part of FDA performance
onsite registration on the day of the publishes in the Federal Register, but
public workshop will be provided commitments under the recent
Web sites are subject to change over reauthorization of the Prescription Drug
beginning at 7:30 a.m. We will let time.
registrants know if registration closes User Fee Act (PDUFA). The
Transcripts: Please be advised that as independent assessment of current
before the day of the public workshop. soon as a transcript of the public
If you need special accommodations practices of FDA and sponsors in
workshop is available, it will be communicating during drug
due to a disability, please contact Susan accessible at https://
Monahan, Center for Devices and development is described in detail in
www.regulations.gov. It may be viewed the document entitled ‘‘PDUFA
Radiological Health, Food and Drug at the Dockets Management Staff (see
Administration, 10903 New Hampshire Reauthorization Performance Goals and
ADDRESSES). A link to the transcript will Procedures Fiscal Years 2018 Through
Ave., Bldg. 32, Rm. 5231, Silver Spring,
also be available on the Internet at 2022’’ available at https://www.fda.gov/
MD 20993–0002, 301–796–5661 or
https://www.fda.gov/MedicalDevices/ downloads/forindustry/userfees/
email: Susan.Monahan@fda.hhs.gov, no
NewsEvents/WorkshopsConferences/ prescriptiondruguserfee/
later than January 16, 2018.
Requests for Oral Presentations: default.htm. ucm511438.pdf. As part of FDA
During online registration, you may IV. Reference performance commitments described in
indicate if you wish to present during a this document, the assessment will be
public comment session and which The following reference is on display conducted by an independent
topic(s) you wish to address. We will do at the Dockets Management Staff (see contractor. FDA is providing for public
ADDRESSES), and is available for viewing comment on the statement of work
our best to accommodate requests to
make public comments and requests to by interested persons between 9 a.m. before revising and requesting
participate in the focused sessions. and 4 p.m., Monday through Friday; it contractor proposals.
Individuals and organizations with is also available electronically at https:// DATES: Submit either electronic or
common interests are urged to www.regulations.gov. FDA has verified written comments by January 22, 2018.
consolidate or coordinate their the Web site addresses, as of the date ADDRESSES: You may submit comments
presentations, and request time for a this document publishes in the Federal as follows. Please note that late,
joint presentation, or submit requests for Register, but Web sites are subject to untimely filed comments will not be
designated representatives to participate change over time. considered. Electronic comments must
in the focused sessions. Following the 1. FDA’s Digital Health Innovation Action be submitted on or before January 22,
close of registration, we will determine Plan issued on July 27, 2017 available at: 2018. The https://www.regulations.gov
the amount of time allotted to each https://www.fda.gov/MedicalDevices/ electronic filing system will accept
presenter and the approximate time DigitalHealth/UCM567265.
comments until midnight Eastern Time
each oral presentation is to begin, and Dated: December 4, 2017. at the end of January 22, 2018.
will select and notify participants by Leslie Kux, Comments received by mail/hand
January 19, 2018. All requests to make Associate Commissioner for Policy. delivery/courier (for written/paper
oral presentations must be received by [FR Doc. 2017–26457 Filed 12–7–17; 8:45 am] submissions) will be considered timely
the close of registration on January 18, if they are postmarked or the delivery
BILLING CODE 4164–01–P
2018, 4 p.m. If selected for presentation, service acceptance receipt is on or
any presentation materials must be before that date.
emailed to Maggie Fu at maggie.fu@ DEPARTMENT OF HEALTH AND You may submit comments as
fda.hhs.gov no later than January 25, HUMAN SERVICES follows:
2018. No commercial or promotional
material will be permitted to be Electronic Submissions
Food and Drug Administration
presented or distributed at the public Submit electronic comments in the
workshop. [Docket No. FDA–2017–N–6313]
following way:
Streaming Webcast of the Public • Federal eRulemaking Portal:
Workshop: This public workshop will Prescription Drug User Fee Act VI https://www.regulations.gov. Follow the
also be webcast. The webcast link will Commitment To Assess Current instructions for submitting comments.
be available on the registration Web Practices of the Food and Drug Comments submitted electronically,
page after January 23, 2018. Please visit including attachments, to https://
sradovich on DSK3GMQ082PROD with NOTICES
Administration and Sponsors in
FDA’s Medical Devices News & Communicating During Investigational www.regulations.gov will be posted to
Events—Workshops & Conferences New Drug Development; Establishment the docket unchanged. Because your
calendar (https://www.fda.gov/ of a Public Docket; Request for comment will be made public, you are
MedicalDevices/NewsEvents/ Comments solely responsible for ensuring that your
WorkshopsConferences/default.htm) comment does not include any
and select this event from the list of AGENCY: Food and Drug Administration, confidential information that you or a
items provided. Organizations are HHS. third party may not wish to be posted,
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Document Created: 2017-12-08 01:43:16
Document Modified: 2017-12-08 01:43:16
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop; request for comments. | |
| 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. | |
| 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] | |
| FR Citation | 82 FR 57988 |
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