What This Bill Does
This bill amends federal medical device laws to require manufacturers to report design changes and reprocessing instruction changes to the government before making them. It also requires manufacturers to report communications about device changes or safety concerns that they send to foreign health care providers within five days. The bill treats rapid assessment tests (quick tests that check if reusable devices have been properly cleaned) as medical devices that need government approval.
Who It Affects
Medical device manufacturers and their business partners. The Food and Drug Administration (FDA), the federal agency that oversees medical devices. Foreign health care providers who receive communications about device changes.
Key Provisions
• Manufacturers must give written notice to the FDA before making any change to a device's design or reprocessing instructions for devices sold across state lines (Sec. 2(b)).
• Manufacturers must tell the FDA within five days after communicating to foreign health care providers about device design changes, reprocessing protocol changes, or safety concerns (Sec. 3(b)).
• Rapid assessment tests designed to ensure reusable medical devices are properly cleaned are now treated as medical devices subject to FDA approval (Sec. 4(a)).
• The FDA must create a list within one year of which rapid assessment tests require manufacturers to submit validated instructions for use and validation data (Sec. 4(b)).
• Starting when the FDA publishes its initial list, the FDA will not approve any rapid assessment test on that list unless the manufacturer includes the required instructions and data (Sec. 4(b)).
What Changes
Device manufacturers must now notify the FDA in writing before changing device designs or cleaning instructions. Manufacturers must also notify the FDA within five days whenever they tell foreign health care providers about device changes or safety issues. Rapid assessment tests used to verify that reusable devices are clean must now go through the FDA approval process like other medical devices.
Important Definitions
"Reusable device" means a medical device intended to be used more than once that must be cleaned, disinfected, or sterilized to stay safe and effective (Sec. 4(a)).
"Affiliate" means a business entity that either controls another business entity or is controlled by another business entity, either directly or indirectly (Sec. 3(b)).
I
118TH CONGRESS
1ST SESSION H. R. 1090
To amend the Federal Food, Drug, and Cosmetic Act to enhance medical
device communications and ensure device cleanliness.
IN THE HOUSE OF REPRESENTATIVES
FEBRUARY 17, 2023
Mr. LIEU (for himself, Ms. CHU, and Ms. NORTON) introduced the following
bill; which was referred to the Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
enhance medical device communications and ensure de-
vice cleanliness.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
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SECTION 1. SHORT TITLE.
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This Act may be cited as the ‘‘Disclosure; and En-
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couragement of Verification, Innovation, Cleaning, and
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Efficiency Act of 2023’’ or the ‘‘DEVICE Act of 2023’’.
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SEC. 2. REPORTING REQUIREMENT FOR DESIGN AND RE-
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PROCESSING INSTRUCTION CHANGES.
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(a) ADULTERATION.—Section 501 of the Federal
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Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amend-
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ed by inserting after paragraph (j) the following:
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‘‘(k) If it is a device with respect to which the manu-
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facturer is in violation of the reporting requirement under
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section 510(r) (relating to design and reprocessing
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changes).’’.
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(b) REQUIREMENT.—Section 510 of the Federal
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Food, Drug, and Cosmetic Act (21 U.S.C. 360) is amend-
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ed by adding at the end the following:
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‘‘(r) REPORTING REQUIREMENT FOR DEVICE DE-
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SIGN CHANGES.—Before making a change to the design
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of a device, or the reprocessing instructions of a device,
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that is marketed in interstate commerce, the manufacturer
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of the device shall give written notice of the change to
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the Secretary.’’.
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SEC. 3. REPORTING REQUIREMENT FOR CERTAIN COMMU-
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NICATIONS TO FOREIGN HEALTH CARE PRO-
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VIDERS.
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(a) ADULTERATION.—Section 501 of the Federal
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Food, Drug, and Cosmetic Act (21 U.S.C. 351), as
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amended by section 2 of this Act, is further amended by
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inserting after paragraph (k) the following:
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‘‘(l) If it is a device with respect to which the manu-
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facturer is in violation of the reporting requirement under
2
section 510(s) (relating to communications to foreign
3
health care providers).’’.
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(b) REQUIREMENT.—Section 510 of the Federal
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Food, Drug, and Cosmetic Act (21 U.S.C. 360), as
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amended by section 2 of this Act, is further amended by
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adding at the end the following:
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‘‘(s) REPORTING REQUIREMENT FOR CERTAIN COM-
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MUNICATIONS TO FOREIGN HEALTH CARE PROVIDERS.—
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‘‘(1) REQUIREMENT.—The manufacturer of a
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device that is marketed in interstate commerce shall
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give written notice to the Secretary of any commu-
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nication described in paragraph (2) not more than
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5 calendar days after making such communication.
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‘‘(2) COMMUNICATION DESCRIBED.—A commu-
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nication is described in this paragraph if the com-
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munication—
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‘‘(A) is made by the manufacturer of the
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device or an affiliate of the manufacturer;
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‘‘(B) relates to a change to the design of
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the device, a change to the recommended re-
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processing protocols, if any, for the device, or a
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safety concern about the device; and
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‘‘(C) is widely disseminated (including on a
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voluntary basis) to health care providers in a
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foreign country.
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‘‘(3) AFFILIATE.—In this subsection, the term
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‘affiliate’ means a business entity that has a rela-
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tionship with a second business entity if, directly or
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indirectly—
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‘‘(A) one business entity controls, or has
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the power to control, the other business entity;
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or
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‘‘(B) a third party controls, or has the
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power to control, both of the business entities.’’.
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SEC. 4. RAPID ASSESSMENT TESTS INTENDED TO ENSURE
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PROPER REPROCESSING.
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(a) INCLUSION
IN DEVICE DEFINITION.—Section
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201 of the Federal Food, Drug, and Cosmetic Act (21
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U.S.C. 321) is amended—
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(1) in paragraph (h)(1)—
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(A) in clause (B), by striking ‘‘or’’ at the
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end;
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(B) in clause (C), by striking ‘‘and’’ at the
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end and inserting ‘‘or’’; and
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(C) by inserting after clause (C) the fol-
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lowing:
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‘‘(D) a rapid assessment test intended to ensure the
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proper reprocessing of a reusable device (as defined in
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paragraph (ss)), and’’; and
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(2) by adding at the end the following:
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‘‘(ss) The term ‘reusable device’ means a device
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that—
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‘‘(1) is intended to be used more than one time;
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and
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‘‘(2) must be sanitized (whether through clean-
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ing, disinfection, or sterilization) to ensure that the
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device is safe and effective for such intended use.’’.
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(b) INSTRUCTIONS
FOR
USE
AND
VALIDATION
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DATA.—Section 510 of the Federal Food, Drug, and Cos-
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metic Act (21 U.S.C. 360), as amended by sections 2 and
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3 of this Act, is further amended by adding at the end
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the following:
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‘‘(t) INSTRUCTIONS
FOR
USE
AND
VALIDATION
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DATA.—
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‘‘(1) INITIAL LIST.—Not later than 1 year after
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the date of enactment of this subsection, the Sec-
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retary shall by regulation develop and publish a list
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of types of rapid assessment tests described in sec-
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tion 201(h)(1)(D) for which reports under sub-
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section (k) must include—
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‘‘(A) instructions for use that have been
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validated in a manner specified by the Sec-
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retary; and
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‘‘(B) validation data, of the types specified
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by the Secretary.
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‘‘(2) UPDATES.—The Secretary shall by regula-
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tion periodically update the list required by para-
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graph (1).
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‘‘(3) ENFORCEMENT.—Beginning on the date
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of publication of the initial list under paragraph (1),
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the Secretary shall not accept any notification under
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subsection (k) for clearance of a type of rapid as-
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sessment test that is included on such list unless
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such notification includes instructions for use and
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validation data in accordance with paragraph (1).’’.
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Æ
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