From MDDI Magazine – Sept 2010 – “FDA has released its long-awaited plans to shore up the 510(k) clearance system used to get many medical devices to market. In August, the agency published a 120-page report to define which devices are appropriate for the approval pathway and when those applications would require additional evidence of both safety and efficacy. These recommendations will be open for public comment.” To read the whole story click here.
Later in the article there are Highlights of Proposed Changes to 510(k)
Stricter 510(k) Process Offers Challenges, Promises