[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19059-19060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08314]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1572]
Cybersecurity of Medical Devices: A Regulatory Science Gap
Analysis; 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), in
association with National Science Foundation (NSF) and Department of
Homeland Security, Science and Technology (DHS S&T) is announcing the
following public workshop entitled ``Cybersecurity of Medical Devices:
A Regulatory Science Gap Analysis.'' The objective of the workshop is
to facilitate a discussion on the current state of regulatory science
in the field of cybersecurity of medical devices, with a focus on
patient safety. The purpose of this public workshop is to catalyze
collaboration among Health Care and Public Health (HPH) stakeholders to
identify regulatory science challenges, discuss innovative strategies
to address those challenges, and encourage proactive development of
analytical tools, processes, and best practices by the stakeholder
community to strengthen medical device cybersecurity.
DATES: The public workshop will be held on May 18 and 19, 2017, from 8
a.m. to 6 p.m. Submit either electronic or written comments on the
public workshop by June 23, 2017. Late untimely filed comments will not
be considered. Electronic comments must be submitted on or before June
23, 2017. The https://www.regulations.gov/ electronic filing system
will accept comments until midnight Eastern Time at the end of June 23,
2017. 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. See
the SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 1503 (The Great Room), Silver
Spring, MD 20993. Entrance for the public workshop participants (non-
FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
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 comments will be
made public, you are solely responsible for ensuring that your comments
do not include any confidential information that you or a third party
may not wish to be public, 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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-1572 for ``Cybersecurity of Medical Devices: A Regulatory
Science Gap Analysis.'' Received comments, those filed in a timely
manner (see DATES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov/ or at the Division of Dockets Management 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 Division of Dockets
Management. 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
[[Page 19060]]
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Dinesh Patwardhan, Food and Drug
Administration, Center for Devices and Radiological Health, 10903 New
Hampshire Ave., Bldg. 64, Rm. 4076, Silver Spring, MD 20993, 301-796-
2622, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Regulatory Science is defined as the science of developing new
tools, standards, and approaches to assess the safety, efficacy,
quality, and performance of all FDA-regulated medical products. At the
Center for Devices and Radiological Health (CDRH), regulatory science
serves to accelerate improving the safety, effectiveness, performance,
and quality of medical devices and radiation-emitting products, and to
facilitate entry of innovative medical devices into the marketplace.
The Regulatory Science Subcommittee of the CDRH Center Science Council
assessed and prioritized the regulatory science gaps for medical
devices based on input from CDRH Offices (https://www.fda.gov/downloads/MedicalDevices/ScienceandResearch/UCM467552.pdf). These new
regulatory science scientific tools, technologies, and approaches form
the bridge to critical 21st century advances in public health.
Cybersecurity of medical devices was identified as one of the top 10
regulatory science gaps. FDA, NSF, and DHS S&T are therefore seeking
input to create a framework to address the cybersecurity regulatory
science gaps. The scope and nature of this cybersecurity regulatory
science research framework is designed to be broad to foster
collaboration across all interested stakeholders. The framework may
include collaborative research conducted between federal agencies such
as NSF, DHS S&T, academia, medical device industry, and third party
experts and other organizations with input from FDA. The collaborative
research may include one or more of the following settings:
1. Intramural cybersecurity research conducted within FDA;
2. Extramural cybersecurity research in collaboration with other
federal agencies (e.g. DHS S&T); and
3. Collaborative long term cybersecurity research conducted among
federal agencies, NSF, academia, medical device industry, and third
party experts and organizations.
This public workshop is not designed to discuss FDA policy
regarding cybersecurity of medical devices.
II. Topics for Discussion at the Public Workshop
The public workshop sessions are planned to include a number of
short opening plenary talks, followed by multiple simultaneous working
sessions organized by broad themes. Attendees are encouraged to
participate in at least one working session of their choice providing
unique views, insights, and challenges.
Following are a list of general topics that are planned to be
included for discussion during the public workshop.
Relationship between medical device cybersecurity and
patient safety;
Unique cybersecurity and regulatory challenges for medical
devices;
Differences in cybersecurity between home care, large
health care providers, and acute care settings (e.g., ambulance,
emergency room);
The roles and intersection of information technology
professionals and biomedical engineering staff;
Potential metrics, evaluation tools to test and quantify
the cybersecurity of medical devices and systems;
Automated and manual tools for communicating cybersecurity
information about medical device design and function;
Best practices for cybersecurity of medical devices at
deployment and how to apply updates throughout the medical device
lifecycle;
Human factor issues in cybersecurity of medical device
development, deployment, and use of devices; and
Best practices in cybersecurity design, deployment, and
post-deployment activities and procedures.
Additional suggested topics may be submitted at the time of
registration.
Each break out session discussion may include following discussion
elements: (1) Immediate cybersecurity challenges and potential
solutions to facilitate entry of innovative medical devices into the
marketplace; (2) Cybersecurity regulatory science gaps to which
solutions can be developed through additional scientific research; and
(3) Long-term cybersecurity research challenges which may need
significant additional basic research.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit
FDA's Medical Devices News & Events--Workshops & Conferences calendar
at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone
number.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop must register by May 4, 2017, by 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
meeting/public workshop will be provided beginning at 8 a.m. We will
let registrants know if registration closes before the day of the
public meeting/public workshop.
If you need special accommodations due to a disability, please
contact Susan Monahan, 301-796-5661, email: [email protected],
no later than May 4, 2017.
Transcripts: Please be advised that as soon as a transcript of the
plenary session portion of the public workshop is available, it will be
accessible at https://www.regulations.gov/. It may be viewed at the
Division of Dockets Management (see ADDRESSES). A link to the
transcript will also be available on the Internet at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this public workshop from the posted events list).
Dated: April 20, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-08314 Filed 4-24-17; 8:45 am]
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