Posts Tagged ‘ Class II medical device ’

New England Journal of Medicine – Medical Devices – Balancing Regulation and Innovation

Jan 19th, 2012 | By
510k 231 wide

January 19, 2012 ~ In a letter to the Editor of the New England Journal of Medicine (NEJM), (here) January 19, 2012, Neil Feder, M.D. of the Project on Government Oversight writes about the 510(k) process that allows untested medical devices onto the market without premarket approval.

Mesh-Injured Patient Reserches ProteGen Mesh Predicate

Nov 18th, 2011 | By
Suzanne McClain

Editors Note* – I first interviewed Suzanne McClain, 45,  in March 2009 and she became part of the series of reports for . She is not just a mesh-injured woman but  has spent hours digging into the FDA’s files to research the predicates for the devices currently on the market.