Yesterday the Institute of Medicine released its report on
Medical Devices and the Public's Health: The FDA 510(k) Clearance Process at 35 Years. The report drew a number of strong reactions.
- Study Faults Approval Process for Medical Devices
by BARRY MEIER, The New York Times, Published: July 29, 2011
- Study of Medical Device Rules Is Attacked, Unseen
by BARRY MEIER, The New York Times, Published: July 27, 2011
- HeartWire has also weighed in.
For more information about the role of software in medical devices in the context of the 510(k) process, see my IOM webcast, the IOM report on Trustworthy Medical Device Software, and publications on the SPQR Lab website. The PDFs are free at the IOM, but there's a clumsy registration process through which one must first wade.
I decided to run the IOM report through Wordle to visualize topics of emphasis. I removed most of the header information before processing. Look below if you want a PDF of higher quality.