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[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 3983 Introduced in Senate (IS)]

<DOC>

117th CONGRESS
  2d Session
                                S. 3983

   To amend the Federal Food, Drug, and Cosmetic Act to require, for 
  purposes of ensuring cybersecurity, the inclusion in any premarket 
     submission for a cyber device of information to demonstrate a 
    reasonable assurance of safety and effectiveness throughout the 
         lifecycle of the cyber device, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             March 31, 2022

  Mr. Cassidy (for himself and Ms. Baldwin) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL

 
   To amend the Federal Food, Drug, and Cosmetic Act to require, for 
  purposes of ensuring cybersecurity, the inclusion in any premarket 
     submission for a cyber device of information to demonstrate a 
    reasonable assurance of safety and effectiveness throughout the 
         lifecycle of the cyber device, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``PATCH Act''.

SEC. 2. ENSURING CYBERSECURITY OF MEDICAL DEVICES.

    (a) In General.--Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at 
the end the following:

``SEC. 524B. ENSURING CYBERSECURITY OF DEVICES.

    ``(a) In General.--For purposes of ensuring cybersecurity 
throughout the lifecycle of a cyber device, any person who submits a 
premarket submission for the cyber device shall include such 
information as the Secretary may require to ensure that the cyber 
device meets such cybersecurity requirements as the Secretary 
determines to be appropriate to demonstrate a reasonable assurance of 
safety and effectiveness, including at a minimum the cybersecurity 
requirements under subsection (b). The Secretary may establish 
exemptions to the requirements under this subsection.
    ``(b) Cybersecurity Requirements.--At a minimum, the manufacturer 
of a cyber device shall meet the following cybersecurity requirements:
            ``(1) The manufacturer shall have a plan to appropriately 
        monitor, identify, and address in a reasonable time postmarket 
        cybersecurity vulnerabilities and exploits.
            ``(2) The manufacturer shall--
                    ``(A) have a plan and procedures for a Coordinated 
                Vulnerability Disclosure to be part of submissions to 
                the Food and Drug Administration; and
                    ``(B) collect and maintain such other information 
                as the Secretary may (by order published in the Federal 
                Register or by other process) require to demonstrate a 
                reasonable assurance of the safety and effectiveness of 
                the cyber device.
            ``(3) The manufacturer shall design, develop, and maintain 
        processes and procedures to make available updates and patches 
        to the cyber device and related systems throughout the 
        lifecycle of the cyber device to address--
                    ``(A) on a reasonably justified regular cycle, 
                known unacceptable vulnerabilities; and
                    ``(B) as soon as possible out of cycle, critical 
                vulnerabilities that could cause uncontrolled risks.
            ``(4) The manufacturer shall furnish to the Secretary a 
        software bill of materials, including commercial, open-sourced, 
        and off-the-shelf software components that will be provided to 
        users.
    ``(c) Substantial Equivalence.--In making a determination of 
substantial equivalence under section 513(i) for a cyber device, the 
Secretary may--
            ``(1) find that cybersecurity information for the cyber 
        device described in the relevant premarket submission in the 
        cyber device's use environment is inadequate; and
            ``(2) issue a nonsubstantial equivalence determination 
        based on this finding.
    ``(d) Definition.--In this section:
            ``(1) The term `cyber device' means a device that--
                    ``(A) includes software; or
                    ``(B) is intended to connect to the internet.
            ``(2) The term `lifecycle of the cyber device' includes the 
        postmarket lifecycle of the cyber device.
            ``(3) The term `premarket submission' means any submission 
        under section 510(k), 513, 515(c), 515(f), or 520(m).''.
    (b) Prohibited Act.--Section 301(q) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331(q)) is amended by adding at the end the 
following:
    ``(3) The failure to comply with any requirement under section 524B 
(relating to ensuring the cybersecurity).''.
    (c) Adulteration.--Section 501 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351) is amended by adding at the end the 
following:
    ``(k) If it is a device with respect to which the sponsor is in 
violation of section 524B (relating to ensuring cybersecurity).''.
    (d) Misbranding.--Section 502(t) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352(t)) is amended--
            (1) by striking ``or (3)'' and inserting ``(3)''; and
            (2) by inserting before the period at the end the 
        following: ``, or (4) to furnish a software bill of materials 
        as required under section 524B (relating to ensuring the 
        cybersecurity)''.
                                 <all>
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