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Today, the U.S. Food and Drug Administration (FDA) issued the following draft guidances:
- The Accreditation Scheme for Conformity Assessment (ASCA) Program
- Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program
- Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program
Under the ASCA program, the FDA grants ASCA Recognition to qualified accreditation bodies to accredit testing laboratories to perform premarket testing for medical device companies. Revised guidances are needed to accommodate the transition of ASCA from a pilot to a permanent program. These guidances include updates to the ASCA program based on feedback from public meetings, webinars, stakeholder meetings, and lessons learned internally during the pilot phase. When final, these guidances will replace the three ASCA Pilot guidances published September 25, 2020.
Note: These guidances are not for implementation at this time.
Submit comments on these draft guidances
Submit comments for these guidances under docket number FDA-2019-D-3805 at www.regulations.gov by November 22, 2024 to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.
Questions?
If you have questions about this draft guidance, contact the ASCA Program or the Division of Industry and Consumer Education.
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