Preventing Superbugs and Protecting Patients Act

Bill: 114-hr-4966
Sponsor: full_name: Rep. Lieu, Ted [D-CA-33]
Introduced: 2016-04-15
Policy area: Health
Subjects: Administrative law and regulatory procedures

Department of Health and Human Services

Drug safety, medical device, and laboratory regulation

Food and Drug Administration (FDA)

Government information and archives

Health technology, devices, supplies

Infectious and parasitic diseases
Latest action: action_date: 2016-04-22
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2016-04-15
action_desc: Introduced in House
text: <p><b>Preventing Superbugs and Protecting Patients Act</b></p> <p>This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to identify types of medical devices for which premarket notification must include proposed labeling, including validated instructions regarding cleaning, disinfection, and sterilization.</p> The FDA must issue final guidance regarding when a premarket notification is required for a modification to a medical device.

tv_txt: I 114th CONGRESS 2d Session H. R. 4966 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.

1. Short title This Act may be cited as the Preventing Superbugs and Protecting Patients Act . 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. . 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.