2012年 10月 19日
The US Food and Drug Administration has published guidance outlining its plans for requiring medical device manufacturers to submit registration materials electronically via the agency’s eCopy Program (PDF).
The eCopy Program is currently voluntary, but will become mandatory upon finalization of the proposed guidance as required by the Food and Drug Administration Safety and Innovation Act signed into law earlier in 2012. Once mandatory, the program will require manufacturers to submit eCopies along with standard application documents in order for the FDA to process and review them. Applications that do not include eCopies of their submissions will be put on hold until applicants provide eCopies. The FDA sees the eCopy Program as a way to expedite the medical device review process.
What to include in an eCopy
The FDA guidance defines an eCopy as an “exact duplicate of the paper submission, created and submitted on a compact disc (CD), digital video disk (DVD), or in another electronic media format.”
An eCopy must include all data required for the type of submission in question. (An applicant’s paper submission may cross-reference the location of pertinent data in the eCopy.) Applicants’ cover letters should describe any discrepancies between the contents of their eCopies and paper submissions.
Medical device submissions that require eCopies
Most medical device registration submission types in the US will fall under the eCopy requirements once the FDA’s rule is finalized. 510(k) premarket notifications as well as Investigational Device Exemptions (IDE) will fall under the eCopy mandate. The only submission types exempt from the rule will be Compassionate Use IDEs, Emergency Use IDEs and Emergency Use Authorizations (EUA).
Common eCopy submission mistakes
The FDA guidance also includes common mistakes applicants make when submitting eCopy files. Errors to look out for, according to the FDA, include:
The FDA is accepting comments on the guidance through mid November 2012.