Industry To FDA: "Emerging Signals" May Do More Harm Than Good

Industry stakeholders have answered the FDA’s call for comments on a draft guidance that proposes an earlier public release of risk data regarding medical devices, even before that data is investigated and analyzed. Several manufacturers — including Abbott and GE Healthcare — as well as the Advanced Medical Technology Association (AdvaMed) argued that information in the suggested safety alerts would be unreliable, could do irreparable damage to valuable products, and could cause unnecessary confusion for patients and providers.

Source: Medical Design Online News - April 5, 2016 Category: Medical Equipment Source Type: news