http://www.fda.gov/downloads/Medica...onandGuidance/GuidanceDocuments/UCM348890.pdf
As of September 14, 2016, this document supersedes Blue Book Memorandum #G95-1 “Use of International Standard ISO-10993, ’Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,’” dated May 1, 1995.
Attachments
-
1.2 MB Views: 759