On the heels of controversy surrounding the US Food and Drug Administration's premarket reviews of medical devices, the agency has commissioned an Institute of Medicine review of its premarket oversight of devices, also called the 510(k) process.
The IOM will conduct 2 public workshops during the next 9 months as part of its review, and will publish its findings in March 2011. In the meantime, the FDA's Center for Devices and Radiological Health will conduct an internal review and work to improve the consistency of the 510(k) process, according to a statement from the agency.
Kuehn BM. Device Review. JAMA. 2009;302(16):1743. doi:10.1001/jama.2009.1530