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510(k) Guidance Footnote May Signal Greater FDA Oversight Of Preclinical Testing

Device industry experts say a seemingly minor footnote to the recent 510(k) program draft guidance could create a new requirement for nonclinical studies.

An easy-to-miss footnote to FDA’s recent 510(k) program draft guidance is attracting the attention of some industry experts as a potential overstepping of agency authority.

The language in question, tucked into the 40-plus-page document issued last month, could create a new requirement for nonclinical studies

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