Devices

3 FDA Guides on Device Accreditation Scheme for Conformity

FDA has issued three medical device-related draft guidances about the agency’s Accreditation Scheme for Conformity Assessment Program. They are:

The Accreditation Scheme for Conformity Assessment (ASCA) Program — FDA announces that it has concluded its earlier ASCA pilot phase and is establishing an ongoing ASCA Program. FDA believes the program advances international harmonization of medical device regulations because it incorporates elements from international conformity assessment practices and standards (e.g., ISO/IEC 17000 series).
Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program — The document includes a list of the FDA-recognized consensus standards and test methods included in the ASCA Program for device biocompatibility testing. It addresses assessment and accreditation of testing laboratories by ASCA-recognized accreditation bodies, and program specifications for the FDA-recognized consensus standards and test methods for biocompatibility testing. It also recommends premarket submission contents specific to FDA-recognized consensus standards and test methods for biocompatibility testing when testing is conducted by an ASCA-accredited testing body.
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 — The guidance addresses the ASCA Program specifications for FDA-recognized consensus standards and test methods for basic safety and essential performance. It also discusses the assessment and accreditation of testing laboratories by ASCA-recognized accreditation bodies. Additionally, it includes the recommended premarket submission contents specific to FDA-recognized consensus standards and test methods for basic safety and essential performance when testing is conducted by an ASCA-accredited testing laboratory.

FDA notes that the three guidances were developed based on feedback from public meetings, Webinars, stakeholder meetings, and lessons learned internally during the pilot phase.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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