FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know
FDA Law Blog
OCTOBER 10, 2023
We find that this information is noteworthy for manufacturers to consider. Animal Testing When engineering analyses and mechanical tests may not comprehensively address the complexities associated with the clinical use of an implant, the draft guidance suggests that an animal study may be necessary to support SE to the predicate device.
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