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FDA Releases ISO 10993-1 Guidance Document

FDA released the long-awaited guidance document for international standard ISO 10993-1 this week. The guidance document represents the current thinking of FDA on the topic of ISO 10993-1 “Biological evaluation of medical devices – Part I: Evaluation and testing within a risk management process.”

Our team is reviewing the document and will provide an assessment of the changes in the near future.

The document can be found  on the FDA website via this LINK.