U.S. Food and Drug Administration

FDA is the federal agency responsible for ensuring that medical devices are safe and effective. FDA standards recognition is for the purpose product submissions to the agency. Conformance with recognized consensus standards is strictly voluntary for a medical device manufacturer. AAMI and ISO standards are used in submissions to the FDA when the FDA recognizes them, but FDA regulation may require additional information beyond what conformity to the recognized consensus standards provides. The FDA's Center for Devices and Radiological Health (CDHR) position has been that decisions about the type of sterilization indicator(s) used and the frequency of their use are the responsibility of the health care facility.

In summary, The FDA ensures that medical devices are safe and effective before they can be sold in the US. AAMI provides guidance on practices for product use. The "ultimate" responsibility of decision making on device and frequency is in the hands of the hospital.