FDA has issued a draft guidance as the first step toward requiring electronic copies for almost all medical device pre-market submissions.
The “eCopy Program for Medical Device Submissions” draft guidance was released Oct. 16
FDA Outlines Mandated eCopy Submission Program In Draft Guidance
The agency issued a draft guidance listing the requirements for its eCopy submission program for medical devices.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.