CDER E2B(R2) Similar Device Combination Products
FDA published revised technical specification in February 2020 covering guidance on Similar device reporting.
As per this guideline, if a reportable malfunction occured using device constituent parts of combination products marketed outside the U.S, then the Combination Product applicant is required to submit Malfunction reports to FDA if the following conditions are met:
- there is a similar device that is part of Combination Product constituent in a U.S. marketed combination product and
- the malfunction is likely to occur in the U.S.marketed combination product
The following are the list of changes made in the release: