The FDA has a requirement for and anticipates a sole source award for direct observance of adverse medical device events to estimate their frequency and discover how and where they are noted in hospital records. This will be part of a high-priority project to improve FDA?s methods of identifying problems with marketed regulated medical devices. The FDA anticipates a sole source award with The University of Utah for and estimated period of performance of 12 months.. Interested parties may inquire about the solicitation no later than August 16, 2002. Submit written inquiries to the FDA/OFACS/Contract Operations Branch, Attn. Chrissy Davidson, HFA-512, 5630 Fishers Lane, Room 2129, Rockville, Maryland 20857-0001.

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