Mediqol

The Food and Drug Administration recently notified manufacturers of 25 different types of Class III medical devices, all marketed prior to 1976 for which PMA’s have not been issued, that further information on their safety and efficacy will be required by 7 August. The FDA is considering whether the products should be subject to a pre-market approval application (PMA) or indeed whether they should be down classified to Class I or Class II.

Here’a link to the FDA news release (http://tinyurl.com/fdapreammend)

It will be very interesting to see if any of these products which have obviously been on the market for a long time are required to go through the PMA process.