A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Kips Bay Medical announced the FDA has granted approval with conditions of Kips Bay Medical’s IDE to include four U.S. study sites in the “eMESH I” clinical feasibility trial of its eSVS Mesh. 4-Traders