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.
In the wake of thousands of permanent injuries and lawsuits over defective medical devices, the FDA has proposed a new plan for postmarket medical device surveillance. This month, the agency released its “Strengthening our National System for Medical Device Postmarket Surveillance” report. Drugwatch