Wednesday, June 15, 2011 7:32 AM
The Assurance Case Approach to Demonstrating Safety in Medical Device Submissions
By Thomas Maeder
The safety assurance case approach helps more reliably design safety into products at an early stage, and communicate the safety arguments in an easier format. However, the burdensome pathway is growing longer and more arduous, and the 510(k) process is migrating closer to a premarket approval. Few understand what an assurance case is or how to construct one, even, some aver, among the CDRH review staff.
External infusion pumps are medical devices used for the controlled delivery of fluids, nutrients, or medications into a patient’s body. Virtually all are Class II devices cleared through the 510(k) process. Approximately two million infusion pumps are used in U.S. hospitals and clinics, plus several hundred thousand more in home care. They are complex devices used by diverse operators in variable circumstances, often to administer critically important substances. more...
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Monday, July 25, 2011 by
"FYI" - a question about this came up during Don Abbey's all-hands meeting
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