Four FDA close-out letters were released in March.

Five FDA close-out letters were released from Feb. 18 through March 31.

Karl Storz didn't have design validation data to show that a brush specified in the instruction manual for its Flex-X² ureteroscope was appropriate for cleaning the device; QS and MDR reg violations identified at maker of coronary bypass cannulas. Six quality-related warning letters were listed by FDA from Dec. 18 through Jan. 14.

The dealmaking column is a survey of recent transactions, including strategic alliances, mergers & acquisitions, and financings, in the life sciences industries. Deals are listed by the following industry sectors: in vitro diagnostics, pharmaceuticals, medical devices, and research/analytical instrumentation and reagents. All transactions are excerpted from Windhover's Strategic Transactions database, providing comprehensive transaction coverage from 1991 to the present.