Have you sent any electronic copies (“e copies”) of submissions to CDRH in the past three weeks? If so, you may have received some feedback about the format of those electronic versions. The important points to remember:
- At present, this is a voluntary program, so as long as you provide enough paper copies, your submission will not be refused.
There was also a resource attached to a message I received describing the requirements for e Copies. I haven’t found this on the web, yet, but can send it to anyone who would like a copy. Just send me an email and I will forward the file to you.
Cheers!
Melissa