U.S Food & Drug Administration administers the Accreditation Scheme for Conformity Assessment (ASCA) Pilot program and recognizes A2LA as an Accreditation Body for laboratories performing premarket testing for medical device companies.
This voluntary program is intended to enhance product reviewers’ and device manufacturers’ confidence in medical device testing through third-party laboratory assessment and accreditation, easing the complex process of pre-market authorization by allowing medical device manufacturers the option to utilize accredited testing laboratories to ensure that data submitted to regulators is met with both confidence and acceptance.
FDA has established the ASCA Pilot Program requirements to describe the process that an organization must follow to have its facility recognized. A2LA is recognized to accredit laboratories globally to this program.
This specialty program is covered under A2LA’s electrical field of testing.
- ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories
- A2LA R256 – Specific Requirements – FDA ASCA Program
- Requirements in FDA ASCA Pilot Program and Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment