510(k) Guidance Footnote May Signal Greater FDA Oversight Of Preclinical Testing
By
Jessica Bylander / Email the Author / “The Gray Sheet” Jan. 23, 2012, Vol. 38, No. 04
Regulatory / Word Count: 916 / Article # 01120123011
Executive Summary
Device industry experts say a seemingly minor footnote to the recent 510(k) program draft guidance could create a new requirement for nonclinical studies.
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