Posts Tagged ‘ reclassification ’

Want to Reclassify a Medical Device? The FDA is all Ears

Nov 15th, 2011 | By
Want to Reclassify a Medical Device? The FDA is all Ears

The Food and Drug Administration on Monday, November 14, announced it will receive public comment on whether or not a medical device should be reclassified to require more or less regulatory oversight. 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.