“To amend the Federal Food, Drug, and Cosmetic Act to enhance medical device communications and ensure device cleanliness.”
No CRS summary available for this bill.
This section requires manufacturers of devices marketed in interstate commerce to provide written notice to the Secretary of Health and Human Services before making a change to the device's design or reprocessing instructions. It deems such a device adulterated if the manufacturer violates this reporting requirement.
This section establishes a reporting requirement under new Section 510(s) of the Federal Food, Drug, and Cosmetic Act requiring manufacturers of devices marketed in interstate commerce—or their affiliates—to provide written notice to the Secretary of Health and Human Services within five calendar days of widely disseminating communications to health care providers in a foreign country regarding (1) a change to the device's design, (2) a change to its recommended reprocessing protocols, or (3) a safety concern about the device. This section further deems such a device adulterated under Section 501(l) if the manufacturer violates this reporting requirement.
This section amends the definition of "device" in the Federal Food, Drug, and Cosmetic Act (FD&C Act) to include rapid assessment tests intended to ensure proper reprocessing of reusable devices—newly defined as devices intended for multiple uses that require sanitization (cleaning, disinfection, or sterilization) for safety and effectiveness. (As background, the FD&C Act definition of device determines FDA regulatory authority over medical instruments, including premarket review under section 510(k) for substantial equivalence to existing devices; reusable devices are common in healthcare settings, where improper reprocessing risks patient infections.) The section further directs FDA, within one year of enactment, to publish and periodically update a list of such test types requiring 510(k) notifications to include validated instructions for use and specified validation data, with enforcement (i.e., rejection of noncompliant notifications) upon initial list publication. (Thus, listed rapid assessment tests become subject to these enhanced premarket requirements.)