The Food and Drug Administration (FDA) has made available for public comment draft guidance titled “eCopy Program for Medical Device Submissions.” Comments are requested by November 16, 2012.

According to FDA, “The draft guidance describes how FDA plans to implement the eCopy Program under the Federal Food, Drug, and Cosmetic Act.” Submitting an electronic copy of a medical device submission is currently voluntary; once the guidance is finalized, however, eCopy submission of certain device submissions will be required. An eCopy does not change “the type or amount of data the applicant includes in a submission to support clearance or approval. An eCopy is defined as an exact duplicate of the paper submission, created and submitted on a compact disc, digital video disc, or in another electronic media format that FDA has agreed to accept, accompanied by a copy of the signed cover letter and the complete original paper submission.” See Federal Register, October 17, 2012.