This resource is the US FDA (Food and Drug Administration) guidance for the pilot phase of the Accreditation Scheme for Conformity Assessment (ASCA).
About this document
Under ASCA, accredited testing laboratories issue test reports against FDA-recognised consensus standards. When a company submits a report from an ASCA-accredited laboratory, the FDA generally does not need to review the detailed test data, making review more efficient. The pilot covered standards such as basic safety and essential performance (IEC 60601 series) and biocompatibility (ISO 10993 series).
Applicable products and users
- Active medical devices (electrical safety and EMC testing)
- Medical devices requiring biocompatibility testing
- Testing laboratories and manufacturers planning to enter the US market
Main contents
- Scope of the ASCA pilot and applicable standards
- Conditions for participation of accreditation bodies and testing laboratories
- How companies use ASCA test reports in their submissions
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Related articles
- US FDA Accreditation Scheme for Conformity Assessment (ASCA) Testing Laboratories
- US FDA Medical Device Registration Services
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Note: this resource is for reference only. Please refer to the latest official version published by the issuing authority.