[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2503 Introduced in Senate (IS)]

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114th CONGRESS
  2d Session
                                S. 2503

  To establish requirements for reusable medical devices relating to 
   cleaning instructions and validation data, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            February 4, 2016

  Mrs. Murray introduced the following bill; which was read twice and 
  referred to the Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
  To establish requirements for reusable medical devices relating to 
   cleaning instructions and validation data, 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 ``Preventing Superbugs and Protecting 
Patients Act''.

SEC. 2. CLEANING INSTRUCTIONS AND VALIDATION DATA 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)(1) Reusable Medical Devices.--Not later than 6 months after 
the date of enactment of this subsection, the Secretary shall identify 
and publish a list of reusable devices or types of devices for which 
reports under subsection (k) must include proposed labeling, including 
instructions for use, which have been validated in a manner specified 
by the Secretary, and validation data, the types of which shall be 
specified by the Secretary, regarding cleaning, disinfection, and 
sterilization, and for which a substantial equivalence determination 
may be based.
    ``(2) The Secretary shall revise such list as necessary with notice 
in the Federal Register.
    ``(3) Reports under subsection (k) that are submitted after the 
publication of the list described in paragraph (1), for devices or 
types of devices included on such list, are required to include such 
labeling and validation data.''.

SEC. 3. DEVICE MODIFICATIONS.

    The Secretary shall issue final guidance regarding when a premarket 
notification under section 510(k) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360(k)) is required to be submitted for a 
modification or change to a legally marketed device not later than 1 
year after the date on which the comment period closes for the draft 
guidance on such subject.
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