FDAnews
www.fdanews.com/articles/138876-fda-releases-long-awaited-device-changes-guidance-industry-reacts

FDA Releases Long-Awaited Device Changes Guidance, Industry Reacts

August 2, 2011
The device industry immediately reacted negatively to the FDA’s release of a draft guidance on 510(k) device modification, saying the requirements could result in an exodus of devicemakers from the U.S.
Devices & Diagnostics Letter