eCopy(electronic copy) is done as a part of submission package for CDRH (Centre for Devices and Radiological Health).

It is an essential part of:

1. 510(k)
2. De novo
3. PMA (Pre market approval)
4. PDP (Product Development Protocol)
5. IDE (Investigational Device Exemptions)
6. IND (Investigational New Drug)
7. BLA (Biologics License Applications) and
8. Pre-submissions

Few details that need attention while working on an eCopy are:

1. Follow the recommended naming convention.
2. Ensure each pdf is within 50 MB.
3. Hardcopy should be an exact duplicate of the eCopy.
4. Ensure there is a separate printed cover letter for eCopy.
5. Send the eCopy on CD/DVD/Flash drive.
6. Cover letter should be enclosed with an eCopy statement.
7. 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 on contact@elexes.com