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eCopy Program for Medical Device Submissions
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eCopy Program for Medical Device Submissions
Website URL:
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM313794.pdf
Category:
Medical
The purpose of this guidance is to explain the new electronic copy (eCopy) Program for medical device submissions. Section 745A(b) of the Federal Food, Drug, and ...
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