With the various amendments to 21 CFR part 803, I am a little bit confused as to what a foreign device manufacturer must do:
Reporting requirements (of a reportable event):
* Medwatch form within 30 days
* or a 5 day Medwatch form report.
Does a foreign (or domestic) manufacturer still complete a baseline report FDA form 3417?
Must the initial importer of a foreign manufacturer report directly to FDA AND to manufacturer when complaints are reportable per MDR?
If the foreign manufacturer is the one sending the Medwatch form (there could be someone else in the US that will receive the complaint and forward the info to the foreign manufacturer) --> does the person/company/group that receives the complain register with the FDA? (establishment registration has now a check box for complaint reporting type of establishment).
Thank you for any clarification on the topic.
Catherine
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Catherine Gloster RAC
Gloster Biomedical International
Santa Barbara CA
United States
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