FDA Begins Review Of Pre-amendments Device Data Submissions

Full article reprinted from “The Gray Sheet” – August 17, 2009

A friendly reminder to pre-amendments device makers: failing to submit the safety and effectiveness information FDA ordered on 25 device types this April could result in seizure, injunction or even criminal prosecution. Read More…

FDA Begins Review Of Pre-amendments Device Data Submissions

Full article reprinted from “The Gray Sheet” – August 17, 2009

A friendly reminder to pre-amendments device makers: failing to submit the safety and effectiveness information FDA ordered on 25 device types this April could result in seizure, injunction or even criminal prosecution.

The information submissions on the specified device categories were due to FDA on Aug. 7, though submissions are still rolling into the agency (1 ‘The Gray Sheet’ April 13, 2009). CDRH has received 120 submissions to date, but expects many more.

Philips Healthcare, for example, maker of the HeartStart home defibrillator, which falls under a pre-amendments device category, says it is still preparing its response to FDA.