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Tag Archives: Class II medical device

510k 231 wide

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

By Mesh Medical Device Newsdesk |

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.

Suzanne McClain

Mesh-Injured Patient Reserches ProteGen Mesh Predicate

By Mesh Medical Device Newsdesk |

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.

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