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.
Halt Medical, a medical device company based in Brentwood, California, announced Tuesday that the Food and Drug Administration has cleared its Acessa device that gynecologists can use to treat female uterine fibroids. MedCity News