A new study has identified important weaknesses in the FDA’s approval of medical devices. The agency can speed devices such as implants, stents or artificial joints through the approval process more quickly if they are substantially equivalent to equipment already on the market.
The law requires that information about the new device be publicly available, but the new study examining 50 recently approved devices found adequate public information on only 16 percent of them. Until safety and effectiveness data about stents, implants and other devices is made available, patients and health professionals are handicapped in making decisions about the best options for treatment.
[JAMA Internal Medicine, online, Sept. 29, 2014]