[US, FDA] Public Workshop –Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices

Summary

The Food and Drug Administration (FDA) is announcing a public workshop entitled “Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices.” The purpose of this public workshop is for the FDA to discuss with stakeholders the expansion of the Accreditation Scheme for Conformity Assessment (ASCA) program to include chemical analysis to support biocompatibility of medical devices.

Background

The workshop will be a public forum for engaging with testing laboratories, device manufacturers, trade associations, accreditation bodies, and the general public. It will focus on stakeholders’ experiences associated with analytical chemistry testing used for medical devices’ toxicological risk assessment. The public workshop is intended to facilitate the sharing of information about analytical chemistry testing and the discussion of pathways for expanding the ASCA program to include standardized approaches to chemical analysis (e.g., ISO10993-18 Biological Evaluation of Medical Devices. Part 18: Chemical characterization of medical device materials within a risk management processExternal Link Disclaimer).

 

 

Public Workshop –Accreditation Scheme for Conformity Assessment and Use of Chemical Analysis to Support Biocompatibility of Medical Devices - 11/06/2024 | FDA

Accreditation Scheme for Conformity Assessment and Use of Chemical Ana

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