This resource is the US FDA (Food and Drug Administration) guidance for the Accreditation Scheme for Conformity Assessment (ASCA) after it moved from a pilot to a permanent program.
About this document
The guidance sets out how the permanent ASCA program operates: how accreditation bodies and testing laboratories obtain ASCA recognition, the requirements laboratories must follow, and what medical device companies should submit when citing test reports from ASCA-accredited laboratories in pre-market submissions. Using ASCA reports can reduce FDA questions on test details and shorten review times.
Applicable products and users
- Medical devices requiring electrical safety, electromagnetic compatibility, biocompatibility and other testing
- Manufacturers preparing 510(k), De Novo or PMA submissions
- Testing laboratories
Main contents
- Requirements for obtaining and maintaining ASCA accreditation
- Scope of applicable FDA-recognised consensus standards
- How to submit ASCA summary test reports in a submission
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Related articles
- US FDA Accreditation Scheme for Conformity Assessment (ASCA) Testing Laboratories
- US FDA Medical Device Registration Services
Need help interpreting this document or assessing its impact on your product? EVERBIZ provides regulatory consulting and registration services – please contact us.
Note: this resource is for reference only. Please refer to the latest official version published by the issuing authority.