United States 117th Congress Status: Died 1 D cosponsors

HR 887 — DEVICE Act of 2021

Last action — Referred to the Subcommittee on Health.

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  1. ✓
    Introduced
  2. ✓
    In Committee
  3. Died in session

This bill died with 117th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

Summary

Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2021 or the DEVICE Act of 2021 This bill addresses design changes and reprocessing of medical devices. Specifically, medical device manufacturers must notify the Food and Drug Administration (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device. (Reprocessing of medical devices is the process for cleaning and sterilizing or disinfecting devices for reuse.) A device may not be sold if the manufacturer violates these notification requirements.

Bill Text

Sections of law this bill changes

3 sections in 1 law

From the bill's own amending language, matched to the official United States Code (current through Public Law 119-124).

Federal food, drug, and cosmetic act · 21 U.S.C. ch. 9 3 sections
  • § 321 Definitions; generally Amends

    21 U.S.C. § 321

    The law today

    For the purposes of this chapter— (a) (1) The term “State”, except as used in the last sentence of section 372(a) of this title, means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico. (2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone. (b) The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body. (c) The term “Department” means Department of Health and Human Services. (d) The term “Secretary” means the Secretary of Health and Human Services. (e) The term “person” includes individual, partnership, corporation, and association. (f) The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. (g) (1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,1 official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specified in clause (A), (B), or (C). A food or dietary supplement for which a claim, subject to sections 343(r)(1)(B) and 343(r)(3) of this title or sections 343(r)(1)(B) and 343(r)(5)(D) of this title, is made in accordance with the requirements of section 343(r) of this title is not a drug solely because the label or the labeling contains such a claim. A food, dietary ingredient, or dietary supplement for which a truthful and not misleading statement is made in accordance with section 343(r)(6) of this title is not a drug under clause (C) solely because the label or the labeling contains such a statement. (2) The term “counterfeit drug” means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor. (h) (1) The term “device” (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is— (A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term “device” does not include software functions excluded pursuant to section 360j(o) of this title. (2) The term “counterfeit device” means a device which, or the container, packaging, or labeling of which, without authorization, bears a trademark, trade name, or other identifying mark or im...

    77 other bills also change this section · Follow it → Official text at uscode.house.gov ↗

  • § 351 Adulterated drugs and devices Amends

    21 U.S.C. § 351

    The law today

    A drug or device shall be deemed to be adulterated— (a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; or (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess; or (3) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if (A) it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of section 379e(a) of this title, or (B) it is a color additive the intended use of which in or on drugs or devices is for purposes of coloring only and is unsafe within the meaning of section 379e(a) of this title; or (5) if it is a new animal drug which is unsafe within the meaning of section 360b of this title; or (6) if it is an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of section 360b of this title. (b) Strength, quality, or purity differing from official compendium If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, except that whenever tests or methods of assay have not been prescribed in such compendium, or such tests or methods of assay as are prescribed are, in the judgment of the Secretary, insufficient for the making of such determination, the Secretary shall bring such fact to the attention of the appropriate body charged with the revision of such compendium, and if such body fails within a reasonable time to prescribe tests or methods of assay which, in the judgment of the Secretary, are sufficient for purposes of this paragraph, then the Secretary shall promulgate regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength, quality, or purity shall be made. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly stated on its label. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homoeopathic drug, in which case it shall be subject to the provisions of the Homoeopathic Pharmacopoeia o...

    95 other bills also change this section · Follow it → Official text at uscode.house.gov ↗

  • § 360 Registration of producers of drugs or devices Amends

    21 U.S.C. § 360

    The law today

    (a) Definitions As used in this section— (1) the term “manufacture, preparation, propagation, compounding, or processing” shall include repackaging or otherwise changing the container, wrapper, or labeling of any drug package or device package in furtherance of the distribution of the drug or device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user; and (2) the term “name” shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation. (b) Annual registration (1) During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary the name of such person, places of business of such person, all such establishments, the unique facility identifier of each such establishment, and a point of contact e-mail address. (2) During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a device or devices shall register with the Secretary his name, places of business, and all such establishments. (3) The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1). The requirement to include a unique facility identifier in a registration under paragraph (1) shall not apply until the date that the identifier system is specified by the Secretary under the preceding sentence. (c) New producers Every person upon first engaging in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs or a device or devices in any establishment which he owns or operates in any State shall immediately register with the Secretary— (1) with respect to drugs, the information described under subsection (b)(1); and (2) with respect to devices, the information described under subsection (b)(2)..1 (d) Additional establishments Every person duly registered in accordance with the foregoing subsections of this section shall immediately register with the Secretary any additional establishment which he owns or operates in any State and in which he begins the manufacture, preparation, propagation, compounding, or processing of a drug or drugs or a device or devices. (e) Registration number; uniform system for identification of devices intended for human use The Secretary may assign a registration number to any person or any establishment registered in accordance with this section. The Secretary may also assign a listing number to each drug or class of drugs listed under subsection (j). Any number assigned pursuant to the preceding sentence shall be the same as that assigned pursuant to the National Drug Code. The Secretary may by regulation prescribe a uniform system for the identification of devices intended for human use and may require that persons who are required to list such devices pursuant to subsection (j) shall list such devices in accordance with such system. (f) Availability of registrations for inspection The Secretary shall make available for inspection, to any person so requesting, any registration filed pursuant to this section; except that any list submitted pursuant to paragraph (3) of subsection (j) and the information accompanying any list or notice filed under paragraph (1) or (2) of that subsection shall be exempt from such inspection unless the Secretary finds that such an exemption would be inconsistent with protection of the public health. (g) Exclusions from application of section The foregoing subsections of this section shall not apply to— (1) pharmacies which maintain establishments in conformance...

    38 other bills also change this section · Follow it → Official text at uscode.house.gov ↗

How this bill changes current law

8 changes Share ↗

Compared against current U.S. Code AI-generated reading aid — verify against the official bill.

The bill amends existing laws governing the adulteration of medical devices and introduces new reporting requirements for manufacturers regarding design changes and communications to foreign health care providers.

  • 21 U.S.C. 351

    (k) If it is a device with respect to which the manufacturer is in violation of the reporting requirement in section 510(r) (relating to design and reprocessing changes).

    Introduces a new condition for adulteration related to violations of reporting requirements for design changes of devices.

  • 21 U.S.C. 360

    (r) Reporting Requirement for Device Design Changes.--Before making a change to the design of a device, or the reprocessing instructions of a device, that is marketed in interstate commerce, the manufacturer of the device shall give written notice of the change to the Food and Drug Administration.

    Establishes a new requirement for manufacturers to notify the FDA of design changes before they are made.

  • 21 U.S.C. 351

    (l) If it is a device with respect to which the manufacturer is in violation of the reporting requirement in section 510(s) (relating to communications to foreign health care providers).

    Adds another condition for adulteration concerning communication violations related to foreign health care providers.

  • 21 U.S.C. 360

    (s) Reporting Requirement for Certain Communications to Foreign Health Care Providers.--The manufacturer of a device that is marketed in interstate commerce shall give written notice to the Food and Drug Administration of any communication described in paragraph (2) not more than 5 calendar days after making such communication.

    Requires manufacturers to report certain communications with foreign health care providers to the FDA within a specified timeframe.

  • 21 U.S.C. 321

    (4) a rapid assessment test intended to ensure the proper reprocessing of a reusable device (as defined in paragraph (ss)),

    Includes rapid assessment tests intended for ensuring proper reprocessing of reusable devices in the definition of devices.

  • 21 U.S.C. 321

    (ss) The term `reusable device' means a device that-- (1) is intended to be used more than one time; and (2) must be sanitized (whether through cleaning, disinfection, or sterilization) to ensure that the device is safe and effective for such intended use.

    Defines 'reusable device' to clarify its sanitization requirements.

  • 21 U.S.C. 360

    (t) Instructions for Use and Validation Data.--(1) Initial list.--Not later than 1 year after the date of enactment of this subsection, the Secretary shall by regulation develop and publish a list of types of rapid assessment tests described in section 201(h)(4) for which reports under subsection (k) must include-- (A) instructions for use that have been validated in a manner specified by the Secretary; and (B) validation data, of the types specified by the Secretary.

    Imposes requirements on the validation and reporting of rapid assessment tests, ensuring their instructions and validation data are included.

  • 21 U.S.C. 360

    (3) Enforcement.--Beginning on the date of publication of the initial list under paragraph (1), the Secretary shall not accept any notification under subsection (k) for clearance of a type of rapid assessment test that is included on such list unless such notification includes instructions for use and validation data in accordance with paragraph (1).

    Establishes enforcement provisions requiring compliance with new reporting standards for rapid assessment tests.

Action History

  1. Referred to the Subcommittee on Health.

  2. Introduced in House

  3. Introduced in House

  4. Referred to the House Committee on Energy and Commerce.

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Subjects

healthcare technology
Cross-referencing the record. Reading this bill against every other bill in the corpus by meaning, not keywords. Only the first open is slow. It’s instant for you after this. Matching · Ranking · Engrossing

Frequently asked questions

What does HR 887 do?
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2021 or the DEVICE Act of 2021 This bill addresses design changes and reprocessing of medical devices. Specifically, medical device manufacturers must notify the Food and Drug Administration (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device. (Reprocessing of medical devices is the process for cleaning and sterilizing or disinfecting devices for reuse.) A device may not be sold if the manufacturer violates these notification requirements.
Who sponsors HR 887?
HR 887 is sponsored by Lieu, Ted (Democratic).
What is the current status of HR 887?
This bill died with 117th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 887?
Track HR 887 free on One Click Politics — get push/email alerts when it moves.

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