New US agent requirements
Donawa, M.
Medical Device Technology 13(1): 35-37
2002
ISSN/ISBN: 1048-6690 PMID: 11921780 Document Number: 543884
The United States (US) Food and Drug Administration (FDA) has recently published a final rule that will require medical device establishments located outside the US and whose products are imported into the US, to register with FDA and identify a US agent. This article discusses the new establishment registration and US agent requirements.