Posts Tagged ‘ Class II medical device ’

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

Jan 19th, 2012 | By
New England Journal of Medicine – Medical Devices – Balancing Regulation and Innovation

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. Share this:



Mesh-Injured Patient Reserches ProteGen Mesh Predicate

Nov 18th, 2011 | By
Mesh-Injured Patient Reserches ProteGen Mesh Predicate

Editors Note* – I first interviewed Suzanne McClain, 45,  in March 2009 and she became part of the series of reports for Injuryboard.com . 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. Share this:



We hope you find this a helpful resource. National News Editor, Jane Akre, began MDND with the hope of providing the latest news, information and perspective from the regulatory, industry and patient point of view, something that goes under-reported in much of the coverage of medical devices. The public is just now becoming aware that many devices do not undergo the same scrutiny as prescription drugs and are instead grandfathered in under an FDA loophole that has gone largely unchanged since the 1970s. As a result, patients become the post-market clinical trial subjects, and many suffer devastating and permanent injuries.