In older fda guidance, the k863 blue book memo which, sadly, has been. New section 5f2 evaluation of automatic class iii designation, guidance for. Program 63086 k863, blue book memorandum rockville, md. Program 630 86 k863, blue book memorandum rockville, md. Figure 1 substantial equivalence decision flow chart. Many items sold by usabluebook require supplemental training, licenses or permits for proper use and may be harmful if not used properly. This approach looks for the same type of question and has a more charitable view of differences if there are accepted scientific methods to evaluate safety and effectiveness and data to demonstrate the new technological characteristics have not diminished safety of effectiveness.
In older fda guidance the k863 blue book memo which, sadly, has been decommissioned, fda stated that in determining whether a device has new technological characteristics, fda should focus on changes that are consequential and require them and only them to be addressed. Items sold by usabluebook are intended for use only by professionals in the water and wastewater treatment industry. Fda blue book memo d861, guidance on significant and nonsignificant risk device studies, july 1986. Vintage guidances for historical research clinical device group. The original designation of digital mammography as class iii is. This guidance was written prior to the february 27, 1997 implementation of fdas good guidance practices, ggps. Fda has three strikes at derailing a product from the 510k path. When does your device raise different questions of safety and. Review program, 510k memorandum k863, dated june 30, 1986. The alphabetical index consists of the three sections, as follows.