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.
American Medical Systems, a medical device manufacturer based in Minnetonka, Minn., announced the recall of its AdVance Male Sling system. According to reports from the company, the absorbable sutures found in the sling assembly degrade before their shelf expiration date. Qmed