Published on the July 29, 2011 DiagnosticImaging.com Web site
By Whitney L.J. Howell
The Institute of Medicine (IOM) released this morning a recommendation for the FDA to abandon its current process for clearing some medical devices for use.
In an unexpected move, the IOM called for an end to the 510(k) clearance process that has been under revision for the past year and proposed that Congress enact legislation for a new regulatory system after the FDA determines how to create one. The 510(k) process is the current pathway that authorizes low-risk medical devices, including those for imaging.
The FDA published its own new recommendations on Tuesday encouraging medical device manufacturers to submit new 510(k) clearance applications when making a change to previously approved devices. The agency also encouraged manufacturers seeking to avoid a second approval to provide scientific justification for any modifications that wouldn’t affect a device’s safety of efficacy.
According to the IOM report, however, current 510(k) revision attempts aren’t sufficient to protect patients or industry.
To read the story in its entirety: http://www.diagnosticimaging.com/practice-management/content/article/113619/1916209