Preventing Superbugs and Protecting Patients Act

1/11/2023, 1:31 PM

Congressional Summary of HR 4966

Preventing Superbugs and Protecting Patients Act

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.

The FDA must issue final guidance regarding when a premarket notification is required for a modification to a medical device.

Current Status of Bill HR 4966

Bill HR 4966 is currently in the status of Bill Introduced since April 15, 2016. Bill HR 4966 was introduced during Congress 114 and was introduced to the House on April 15, 2016.  Bill HR 4966's most recent activity was Referred to the Subcommittee on Health. as of April 22, 2016

Bipartisan Support of Bill HR 4966

Total Number of Sponsors
1
Democrat Sponsors
1
Republican Sponsors
0
Unaffiliated Sponsors
0
Total Number of Cosponsors
8
Democrat Cosponsors
7
Republican Cosponsors
1
Unaffiliated Cosponsors
0

Policy Area and Potential Impact of Bill HR 4966

Primary Policy Focus

Health

Potential Impact Areas

Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government information and archivesHealth technology, devices, suppliesInfectious and parasitic diseases

Alternate Title(s) of Bill HR 4966

Preventing Superbugs and Protecting Patients ActTo establish requirements for reusable medical devices relating to cleaning instructions and validation data, and for other purposes.Preventing Superbugs and Protecting Patients Act
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