[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4966 Introduced in House (IH)]

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114th CONGRESS
  2d Session
                                H. R. 4966

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 15, 2016

Mr. Ted Lieu of California (for himself and Mr. Roskam) introduced the 
   following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 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) Reusable Medical Devices.--(1) Not later than 6 months after 
the date of enactment of this subsection, the Secretary shall identify 
and publish a list of reusable device types for which reports under 
subsection (k) must include 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 
instructions for use and validation data.''.

SEC. 3. DEVICE MODIFICATIONS.

    The Secretary of Health and Human Services, acting through the 
Commissioner of Food and Drugs, 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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