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Guidance Documents/Guidance-Document/Distinguishing Medical Device Recalls from Medical Device Enhancements: Guidance for Industry and Food and Drug Administration Staff

Distinguishing Medical Device Recalls from Medical Device Enhancements: Guidance for Industry and Food and Drug Administration Staff

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

October 15, 2014

February 26, 2019

Center for Devices and Radiological Health

3008fb0d-36fe-4243-9d66-88213ff44246

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