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

<DOC>





                                                       Calendar No. 417
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

                             April 5, 2016

              Reported by Mr. Alexander, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Preventing Superbugs and 
Protecting Patients Act''.</DELETED>

<DELETED>SEC. 2. CLEANING INSTRUCTIONS AND VALIDATION DATA 
              REQUIREMENT.</DELETED>

<DELETED>    Section 510 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360) is amended by adding at the end the 
following:</DELETED>
<DELETED>    ``(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.</DELETED>
<DELETED>    ``(2) The Secretary shall revise such list as necessary 
with notice in the Federal Register.</DELETED>
<DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 3. DEVICE MODIFICATIONS.</DELETED>

<DELETED>    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.</DELETED>

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 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.
                                                       Calendar No. 417

114th CONGRESS

  2d Session

                                S. 2503

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                             April 5, 2016

                       Reported with an amendment