No More Paper: All Medical Device Submission to FDA to be Electronic Only
[Thursday, September 13, 2018]

This week FDA proposed a change to the medical device submission rules whereby all 510k, IDE and PMA submissions will only be accepted electronically; paper copies will no longer be accepted. Since 2013, FDA has accepted eCopies of the paper submission. The applicants were required to prepare at least one fully compiled printed copy of the application or any amendments to it and mail it to the FDA along with a full electronic copy of the same. The FDA guidance on eCopy describes the specifications of the electronic files (mostly PDF files) in terms of the size of the file, the split into multiple files, file naming rules, and media on which to copy the files for submission. Under the new rule, the paper copy will be eliminated and the eCopy will become the only copy sent to the FDA. The eCopy guidance will still be effective, but the cover letter will no longer need the certification saying that the eCopy is an exact copy of the paper submission. The eCopy, prepared per the FDA guidance, can be copied onto a CD, DVD or a flash drive and mailed or hand carried to the CDRH Document Room at the address on FDA’s website. FDA will also accept medical device applications submitted via the Electronic Submission Gateway, just like it does for the applications for drugs and biologics. To create medical device applications for submission, it is strongly recommended to use FDA’s eSubmitter software which is available free of cost at the FDA website. This rule was much needed. It brings the CDRH in line with the other centers for market approval and clinical trial applications. The next step should be for FDA to also update the 510k, IDE and PMA application formats for electronic submission. Hope that happens soon as well.