[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4965 Introduced in House (IH)]

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114th CONGRESS
  2d Session
                                H. R. 4965

 To amend the Federal Food, Drug, and Cosmetic Act to enhance medical 
          device communications and ensure device cleanliness.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 15, 2016

  Mr. Ted Lieu of California 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 device cleanliness.

    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 ``Disclosure; and Encouragement of 
Verification, Innovation, Cleaning, and Efficiency Act of 2016''.

SEC. 2. REPORTING REQUIREMENT FOR DESIGN AND REPROCESSING INSTRUCTION 
              CHANGES.

    (a) Adulteration.--Section 501 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph 
(j) the following:
    ``(k) If it is a device with respect to which the manufacturer is 
in violation of the reporting requirement in section 510(q) (relating 
to design and reprocessing changes).''.
    (b) Requirement.--Section 510 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360) is amended by adding at the end the 
following:
    ``(q) 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.''.

SEC. 3. REPORTING REQUIREMENT FOR CERTAIN COMMUNICATIONS TO FOREIGN 
              HEALTH CARE PROVIDERS.

    (a) Adulteration.--Section 501 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 351), as amended by section 2 of this Act, is 
further amended by inserting after paragraph (k) the following:
    ``(l) If it is a device with respect to which the manufacturer is 
in violation of the reporting requirement in section 510(r) (relating 
to communications to foreign health care providers).''.
    (b) Requirement.--Section 510 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360), as amended by section 2 of this Act, is 
further amended by adding at the end the following:
    ``(r) Reporting Requirement for Certain Communications to Foreign 
Health Care Providers.--
            ``(1) Requirement.--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.
            ``(2) Communication described.--A communication is 
        described in this paragraph if the communication--
                    ``(A) is made by the manufacturer of the device or 
                an affiliate of the manufacturer;
                    ``(B) relates to a change to the design of the 
                device, a change to the recommended reprocessing 
                protocols, if any, for the device, or a safety concern 
                about the device; and
                    ``(C) is widely disseminated (including on a 
                voluntary basis) to health care providers in a foreign 
                country.
            ``(3) Affiliate.--In this subsection, the term `affiliate' 
        means a business entity that has a relationship with a second 
        business entity if, directly or indirectly--
                    ``(A) one business entity controls, or has the 
                power to control, the other business entity; or
                    ``(B) a third party controls, or has the power to 
                control, both of the business entities.''.

SEC. 4. RAPID ASSESSMENT TESTS INTENDED TO ENSURE PROPER REPROCESSING.

    (a) Inclusion in Device Definition.--Section 201 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended--
            (1) in paragraph (h)--
                    (A) in subparagraph (2), by striking ``or'' at the 
                end;
                    (B) in subparagraph (3), by striking ``and'' at the 
                end and inserting ``or''; and
                    (C) by inserting after subparagraph (3) the 
                following:
            ``(4) a rapid assessment test intended to ensure the proper 
        reprocessing of a reusable device (as defined in paragraph 
        (ss)), and''; and
            (2) by adding at the end the following:
    ``(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.''.
    (b) Instructions for Use and Validation Data.--Section 510 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360), as amended by 
sections 2 and 3 of this Act, is further amended by adding at the end 
the following:
    ``(s) 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.
            ``(2) Updates.--The Secretary shall by regulation 
        periodically update the list required by paragraph (1).
            ``(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).''.
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