If we report to MedSun, do we still have to report adverse medical device events to FDA and manufacturers on MedWatch Form 3500A?
A. No. Filing reports through MedSun fulfills your requirement to respond to FDA under the Safe Medical Devices Act (SMDA). In addition, representatives can indicate that they want a copy of the MedSun report sent on their behalf to the manufacturer, thus fulfilling their reporting requirement under SMDA.
Related Questions
- If we report to MedSun, do we still have to report adverse medical device events to FDA and manufacturers on MedWatch Form 3500A?
- Where can I find the reporting codes for adverse events that I use with medical device reports?
- Is the importer required to report adverse events to FDA and to the manufacturer?
