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GUIDANCE DOCUMENT

Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Program Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff September 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2019-D-3805
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

This guidance provides information on how the Biological Evaluation of Medical Devices standards are incorporated into the Accreditation Scheme for Conformity Assessment Program (hereafter referred to as the ASCA Program). The ASCA Program is described in FDA’s draft guidance, The Accreditation Scheme for Conformity Assessment (ASCA) Program.

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