Program 630 86 k863, blue book memorandum rockville, md. Fda has three strikes at derailing a product from the 510k path. 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. Fda often sees no data, speaks no data, hears no data. In older fda guidance, the k863 blue book memo which, sadly, has been. When does your device raise different questions of safety and. This guidance was written prior to the february 27, 1997 implementation of fdas good guidance practices, ggps. Evaluating substantial equivalence in premarket notifications. Fda blue book memo d861, guidance on significant and nonsignificant risk device studies, july 1986. It does not create or confer rights for or on any person and does not operate to bind fda or the public. The original designation of digital mammography as class iii is. The alphabetical index consists of the three sections, as follows.
Fda, guidelines for monitoring clinical investigations, january 1988. Program 63086 k863, blue book memorandum rockville, md. 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. We hope you find these blue book memos helpful in your understanding of. The ode guidance memoranda, affectionately referred to as blue book memos, clarify these guidelines and will be added to this list as they become available. Vintage guidances for historical research clinical device group. Many items sold by usabluebook require supplemental training, licenses or permits for proper use and may be harmful if not used properly. Review program, 510k memorandum k863, dated june 30, 1986. Icd10 international statistical classification of diseases and related. Items sold by usabluebook are intended for use only by professionals in the water and wastewater treatment industry. Figure 1 substantial equivalence decision flow chart. New section 5f2 evaluation of automatic class iii designation, guidance for.