Researchers Are Taking on The FDA – Good Cause and About Time

This is very timely as cardiovascular devices are changing rapidly, now many are devices that report data too. So many still seem to think Health IT and the clinical side of the business are 2 separate items, they are not. All of healthcare is changing in this area and they are married at at hip.

If you are only looking at the clinical side of the business as relates to medical devices, then only half is getting done. Kudos to the researchers who are bringing this to the limelight. I write about this item quite frequently and again the ramifications on what happens with both entities combined is largely over looked. I will definitely be a follower on this effort. BD

The Medical Quack: Wireless Healthcare Medical Devices and the FDA ...

Wireless Healthcare Medical Devices and the FDA – The Reasons They Are Slow to Come to Terms

Researchers Sanket Dhruva and Rita Redberg on the hornet's nest they stirred up with their study of the Food & Drug Administration's approval process for high-risk cardiovascular devices.

It's not often that a few doctors ensconced in the ivy towers of academia can get a lumbering dinosaur like the Food & Drug Administration to turn on a dime, let alone during the week between Christmas and the new year.

But that's exactly what University of California at San Francisco researchers Sanket S. Dhruva, Lisa Bero and Rita Redberg did after the Journal of the American Medical Assn. published their paper "Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices."

The study, which looked at 78 pre-market approvals for cardiovascular devices from 2000 to 2008, touched such a nerve at the Rockville, Md., headquarters of the FDA that acting Center for Devices and Radiological Health head honcho Jeffrey Shuren had the watchdog agency's own internal study of the device approval process released early. Shuren, during a spin control session with the New York Times, conceded the researchers' main point: The agency needs to do a better job regulating the evidence used to clear medical devices

Researchers take on the FDA | Medical Device Industry Features & Profiles - MassDevice