Reclassification guidance in the works
This article was originally published in The Gray Sheet
Executive Summary
FDA's premarket notification staff is developing a guidance document to clarify the "convoluted" device reclassification process, section director Heather Rosecrans said Oct. 17 at the Regulatory Affairs Professionals Society annual meeting in Baltimore. Retired FDA staffer Joe Sheehan wrote the reclassification regulations and will be under contract to help with the guidelines, Rosecrans said. In 2006, the office also plans to write a guidance for special 510(k)s and update the 1998 510(k) paradigm guidance document, as well as draft rules on device convenience kits and transferring ownership of 510(k)s...