[Federal Register Volume 88, Number 186 (Wednesday, September 27, 2023)]
[Notices]
[Pages 66458-66460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20955]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-D-1158]
Cybersecurity in Medical Devices: Quality System Considerations
and Content of Premarket Submissions; 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 a final guidance entitled ``Cybersecurity in
Medical Devices: Quality System Considerations and Content of Premarket
Submissions.'' As more medical devices are becoming interconnected,
cybersecurity threats have become more numerous, more frequent, more
severe, and more clinically impactful. As a result, ensuring medical
device safety and effectiveness includes adequate medical device
cybersecurity, as well as its security as part of the larger system.
This final guidance supersedes the final guidance ``Content of
Premarket Submissions for Management of Cybersecurity in Medical
Devices,'' issued October 2, 2014.
DATES: The announcement of the guidance is published in the Federal
Register on September 27, 2023.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
[[Page 66459]]
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-2021-D-1158 for ``Cybersecurity in Medical Devices: Quality System
Considerations and Content of Premarket Submissions.'' 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, 240-402-7500.
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.govinfo.gov/content/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, 240-402-7500.
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 guidance document entitled
``Cybersecurity in Medical Devices: Quality System Considerations and
Content of Premarket Submissions'' to the Office of Policy, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.
FOR FURTHER INFORMATION CONTACT: Suzanne Schwartz, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5410, Silver Spring, MD 20993-0002, 301-
796-6937; or Anne Taylor, 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
With the increasing integration of wireless, internet- and network-
connected capabilities, portable media (e.g., USB or CD), and the
frequent electronic exchange of medical device-related health
information and other information, the need for robust cybersecurity
controls to ensure medical device safety and effectiveness has become
more important. In addition, cybersecurity threats to the healthcare
sector have become more frequent and more severe, carrying increased
potential for clinical impact. Cybersecurity incidents have rendered
medical devices and hospital networks inoperable, disrupting the
delivery of patient care across healthcare facilities in the United
States and globally. Such cyberattacks and exploits may lead to patient
harm as a result of clinical hazards, such as delay in diagnoses and/or
treatment. As a result, ensuring device safety and effectiveness
includes adequate device cybersecurity, as well as its security as part
of the larger system.
Additionally, section 3305 of the Consolidated Appropriations Act,
2023, enacted on December 29, 2022, added section 524B ``Ensuring
Cybersecurity of Medical Devices'' to the Federal Food, Drug, and
Cosmetic Act (FD&C Act). Under section 524B(a) of the FD&C Act, a
person who submits a 510(k), premarket approval application (PMA),
product development protocol, De Novo, or Humanitarian Device Exemption
for a device that meets the definition of a cyber device, as defined
under section 524B(c) of the FD&C Act, is required to submit
information to ensure that cyber devices meet the cybersecurity
requirements under section 524B(b) of the FD&C Act. Section 524B(c) of
the FD&C Act defines ``cyber device'' as a device that includes
software validated, installed, or authorized by the sponsor as a device
or in a device; has the ability to connect to the internet; and
contains any such technological characteristics validated, installed,
or authorized by the sponsor that could be vulnerable to cybersecurity
threats. The recommendations in this guidance are intended to help
manufacturers meet their obligations under section 524B of the FD&C
Act.
This final guidance supersedes the final guidance ``Content of
Premarket
[[Page 66460]]
Submissions for Management of Cybersecurity in Medical Devices,''
issued October 2, 2014. The changes since the 2014 guidance are
intended to further emphasize the importance of ensuring that devices
are designed securely and are designed to be capable of mitigating
emerging cybersecurity risks throughout the total product lifecycle
(TPLC), and to clearly outline FDA's recommendations for premarket
submission information to address cybersecurity concerns. As discussed
in the guidance, one way these TPLC considerations for devices can be
achieved is through the implementation and adoption of the Secure
Product Development Framework. The recommendations in this guidance are
intended to promote consistency, facilitate efficient premarket review,
and help ensure that marketed medical devices are sufficiently
resilient to cybersecurity threats.
A notice of availability of the draft guidance appeared in the
Federal Register of April 8, 2022 (87 FR 20873). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including aligning with industry best practices, as
well as further clarifying the level of documentation recommended.
Additionally, we have clarified interoperability considerations and
that cybersecurity controls should not be intended to prohibit a user
from accessing their device data.
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Cybersecurity in Medical Devices: Quality
System Considerations and Content of Premarket Submissions.'' 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.
II. Electronic Access
Persons interested in obtaining a copy of the 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of
``Cybersecurity in Medical Devices: Quality System Considerations and
Content of Premarket Submissions'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number GUI00001825 and complete title to
identify the guidance you are requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget under the Paperwork Reduction Act
of 1995. The collections of information in the following FDA
regulations, guidance, and forms 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
814, subpart H.................... Humanitarian Use 0910-0332
Devices;
Humanitarian Device
Exemption.
812............................... Investigational 0910-0078
Device Exemption.
860, subpart D.................... De Novo 0910-0844
classification
process.
``Requests for Feedback and Q-Submissions and 0910-0756
Meetings for Medical Device early payor
Submissions: The Q-Submission feedback request
Program''. programs for
medical devices.
800, 801, 809, and 830............ Medical device 0910-0485
labeling
regulations; Unique
device
identification.
820............................... Current good 0910-0073
manufacturing
practice (CGMP);
Quality system (QS)
regulation.
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Dated: September 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20955 Filed 9-26-23; 8:45 am]
BILLING CODE 4164-01-P