Medical Devices

FDA proposes guidance on PMAs
By Stephanie Bouchard | 10:23 am | August 16, 2011
The U.S. Food and Drug Administration is seeking to offer clarity to manufacturers and reviewers of medical devices. The agency released proposed guidance on how benefit-risk determinations are made during premarket review and how researchers and manufacturers can design better quality clinical studies.
FDA should replace medical devices clearance program
By Stephanie Bouchard | 02:07 pm | July 29, 2011
The U.S. Food and Drug Administration should replace its 35-year-old 510(k) clearance process for medical devices, says a new report issued by the Institute of Medicine.
Patients deserve to know costs of medical devices
By Ed Howe | 11:20 am | April 21, 2011
We can compare the price of a new car or appliance but when it comes to certain medical devices, including implants, the costs are kept from patients, hospitals and even the government.