Baby Steps: FDA Device eCopy Draft Guidance

Written by Joel Finkle, Senior Strategist, Regulatory Services Delivery

I know I promised more information on the FDA Promotional Materials guidance for Module 1 to be implemented next year, but there’s some breaking news: FDA has released draft guidance on e-submissions permitted for all medical device filings.

As announced in the Federal Register on October 17, FDA has released draft guidance, with a 30-day comment period ending November 16, 2012. Use the regulations.gov website for comments, using docket # FDA-2012-D-1056.

The most significant item in the guidance is the note that FDA will like they are with eCTDs for drug products requiring electronic submission 24 months after this guidance is finalized. This is a requirement of the FD&C Act section 745A(b), and section 1136 of the FDASIA regulations. It’s pretty stern stuff: submissions without an eCopy will be placed “on hold” and the clock will not start until the eCopy is received there will be exemptions, but since the technology is mature, no waivers will be granted. FDA is considering the eCopy to be the official record in this case (note: Device companies will need to look into 21 CFR Part 11 for eSubmissions welcome to the club!)

The good news is that the eCopy is designed to be an exact copy of a paper filing, and as such, there are no new reporting or data requirements. The only differences permitted are those where electronic submission is technologically different such as medical imaging, data submission, etc. The paper version can have cross-references to additional information in the eCopy version, but the eCopy version must be complete and not refer back to the paper. Since it is an exact copy, it counts as one of the copies that must be sent, meaning less paper and transportation cost at the very least.

What do you mean by “baby steps"?
The eCopy guidance FDA has issued is very, very similar to the original eNDA guidance dating all the way back to 1999 (and to the current EU NeES guidance), incorporating the last thirteen years’ lessons to a small extent (newer versions of Acrobat, putting a sequence number of PDF files). But it’s not going far enough: There’s no reason why this should be a simple “eCopy” instead of a full “e-Submission” when we’ve had 9 years of eCTD experience.

Most significant, if FDA does not finalize this guidance for a year (which is typical), and the requirement to e-File is two years after that, we’re right in the middle of FDA’s implementation of eCTD 4 based on HL7’s RPS in 2015. CDRH is an active participant in the RPS process, and while they may not implement RPS as quickly as CDER and CBER, they shouldn’t need to be too far behind.

Establishing a very NeES-like precedent for devices is going to doom FDA to receiving this format for years to come. Sure, you need to walk before you can run, but with a “big brother” already taking huge strides, it should be a shorter route to full e-submissions than this one.

What must be done?
eCopies will be required for the following submission types to CDRH:

• Premarket notification submissions (510(k)s), including third party 510(k)s
• Evaluation of automatic class III designation petitions (de novos)
• Premarket approval applications (PMAs), including Modular and Transitional
• Product development protocols (PDPs)
• Investigational device exemptions (IDEs)
• Humanitarian device exemptions (HDEs), including Humanitarian Use Device designation requests (HUDs)
• Certain investigational new drug applications (INDs) and biologics license applications (BLAs) Pre-Submissions

However, exemptions are provided for Compassionate and Emergency Use IDEs and Emergency Use authorizations. You may submit an eCopy, but they will not require it. If a device submission would be sent entirely to CBER, you should follow CBER’s eSubmission rules instead.

How to create Device eCopies
FDA is providing a tool for assembling and submitting eCopies, which can be downloaded at the following web address:

http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm317334.htm

This is the same tool currently in use for ICSRs, Registrations and Listings, and other submissions, although the eCopy assembly capability is new. At this point, it appears that CDRH is expecting physical media (CDs, DVDs, etc.), and will not be using the FDA Gateway or WebTrader.

Submissions can be organized by volume (all content for one volume in a folder or a single PDF per volume), or non-volumized (one PDF for each Table of Contents item, or one PDF in total). The only folders permitted are per volume. Surprisingly, FDA is accepting Acrobat 10.0 format.

Everything should be PDF except for statistical data and “miscellaneous” files (such as imaging or source code), which must be provided in ZIP files. PDF files should be named with a 3-digit prefix indicating the TOC order, and should be under 50MB each. The rest of the formatting rules (bookmarking, fonts, page orientation, etc.) should be familiar to anyone who has done electronic submissions since 1999.

The guidance can be found here (PDF).