FDA’s New Draft Guidance on 510(k) Implant Devices: What You Need to Know
FDA Law Blog
OCTOBER 10, 2023
In the case of 510(k) Implants indicated for use in pediatric patients, FDA recommends consulting two other guidance documents: Pediatrics Guidance and Extrapolation Guidance. Information about these typical non-clinical tests is generally based on previously released guidance documents for each topic, as linked above.
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