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:
- De novo
- PMA (Pre market approval)
- PDP (Product Development Protocol)
- IDE (Investigational Device Exemptions)
- IND (Investigational New Drug)
- BLA (Biologics License Applications) and
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 eCopy.
- Ensure there is a separate printed cover letter for eCopy.
- Send the eCopy on CD/DVD/Flash drive.
- 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 on firstname.lastname@example.org