Category Archives: Microbiology

Dissecting the FDA’s Expectations for Biocompatibility of Medical Devices: Five Key Considerations

The FDA issued a long-awaited final guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process replacing the historical "Blue Book Memorandum #G95-1" (1995). The new guidance, released in June, is a substantial upgrade from its predecessor and serves the purpose of guiding…
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