eCopy(electronic copy) is done as a part of the submission package for CDRH (Centre for Devices and Radiological Health). Today, we are going to list some essential parts of an eCopy that one should pay attention to.
PDP (Product Development Protocol)
IDE (Investigational Device Exemptions)
IND (Investigational New Drug)
BLA (Biologics License Applications)
A few details that need attention while working on an eCopy are:
Follow the recommended naming convention.
Ensure each pdf is within 50 MB.
Hardcopy should be an exact duplicate of the copy.
Ensure there is a separate printed cover letter for eCopy.
Send the eCopy on a CD/DVD/Flash drive.
The cover letter should be enclosed with an eCopy statement.
More than 1 CD is not allowed, if the data exceeds the capacity of the CD, then the copy should ideally be sent on a pen drive.
For further details on eCopy and its submission guidance, do write to us at [email protected] or check our complete guide - eCopy Medical Device Submission (How to create a successful eCopy?)