Excerpt from AAMI nexUS 2024 meeting where Dr. Shuren from the FDA spoke about Standards, and the ASCA effort. Acertara is the only FDA ASCA accredited laboratory for ultrasound testing. "Right now, the Accreditation Scheme for Conformity Assessment (ASCA) is an important opportunity for manufacturers. Dr. Shuren described ASCA as a “highly valuable program,” which is voluntary and meant to “leverage the international conformity assessment structure.” As of 2023, the program is permanent and relies heavily on voluntary consensus standards and functions as a “build out” of CDRH’s work with standards. Dr. Shuren touted ASCA’s benefits, such as dramatically reduced time needed for conformity assessment, certainty regarding what documentation is needed, and improved testing quality. So far, ASCA has enjoyed noteworthy success, and per Dr. Shuren, medical device sponsors are strongly encouraged to participate."
