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FDA Outlines Mandated eCopy Submission Program In Draft Guidance

The agency issued a draft guidance listing the requirements for its eCopy submission program for medical devices. An eCopy will be mandatory for all device firms after the draft is finalized.

FDA has issued a draft guidance as the first step toward requiring electronic copies for almost all medical device pre-market submissions.

The “eCopy Program for Medical Device Submissions” draft guidance was released Oct. 16. It defines a medical device eCopy submission as “an exact duplicate of the paper submission,...

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