Did you know that section 745A (b) of the Federal Food, Drug, and Cosmetic (FD&C) Act requires submission of electronic copies (eCopy) for medical device submissions?
The United States (US) Food and Drug Administration (FDA) has issued a guidance describing the eCopy program, including the standards for a valid eCopy submission. Medical device submission types which are identified in this guidance must include an eCopy for the submission to be processed and accepted for review by the FDA, but for exemptions and waivers.
An eCopy is an electronic version of a medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or a flash drive. It must be accompanied by a paper copy of the signed cover letter. It must be noted that an eCopy is not considered to be an eSubmission, which is a submission package produced by an electronic submission template. While an eCopy consists of only electronic documents that are human readable, an eSubmission contains documents intended for computer processing as well as human readable documents.
“An eCopy can be considered a static representation of the submission, while an eSubmission can be considered a dynamic representation of the submission.”
The guidance lists the types of submissions for which an eCopy is required, and also submission types for which eCopy legislation does not apply but may still be submitted. Then it outlines the technical standards, recommended methods and special considerations for creating an eCopy submission. Further questions and answers are provided on various issues surrounding eCopy submissions.
The guidance recommends that applicants verify an eCopy using the free Validation Module on the FDA website, in order to ensure it meets the required standards. If an eCopy is not accepted by the FDA, the file will be placed on hold until a valid replacement copy is provided.
This eCopy Program is proposed to improve the efficiency of the FDA’s review process, by enabling the instant availability of an electronic version rather than relying on the paper version. To view the full guidance, click here.