A US FDA medical device update, Part II
Donawa, M.E.
Medical Device Technology 7(7): 12-6 18
1996
ISSN/ISBN: 1048-6690 PMID: 10163518 Document Number: 455241
This column in last month's edition discussed answers to some of the questions raised at a recent Food and Drug Administration (FDA) conference held in Paris. This article continues that discussion and includes questions and answers concerning harmonization and good manufacturing practice (GMP) requirements. As in the preceding column, the answers were provided by FDA speakers at the conference or subsequently confirmed in discussions with the author.