Directs the Secretary of Health and Human Services to review, according to specified criteria, a Class I or Class II reprocessed device whose producer is exempt from having to report preceding the device's introduction into state commerce. Requires the Secretary to publish in the Federal Register a list of such devices that are no longer exempt.
Declares that the termination of an exemption from reporting requirements for a reprocessed device shall not terminate the exemption for the original device.
Directs the Secretary to perform specified duties with respect to those reprocessed single-use devices that require reports, including to require validation data. Prohibits the Secretary from determining that such a device is misbranded or adulterated or from taking action against the device for a failure to provide certain required information unless one of specified conditions are met, including that the device is not substantially equivalent to a predicate device. Prohibits marketing the device if it is not substantially equivalent.