Nnblue book memo k86-3

We hope you find these blue book memos helpful in your understanding of. Fda has three strikes at derailing a product from the 510k path. Program 63086 k863, blue book memorandum rockville, md. Fda, guidelines for monitoring clinical investigations, january 1988. Review program, 510k memorandum k863, dated june 30, 1986. It does not create or confer rights for or on any person and does not operate to bind fda or the public. In older fda guidance, the k863 blue book memo which, sadly, has been. New section 5f2 evaluation of automatic class iii designation, guidance for. 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. The original designation of digital mammography as class iii is. Items sold by usabluebook are intended for use only by professionals in the water and wastewater treatment industry. The alphabetical index consists of the three sections, as follows.

Program 630 86 k863, blue book memorandum rockville, md. Fda blue book memo d861, guidance on significant and nonsignificant risk device studies, july 1986. Icd10 international statistical classification of diseases and related. 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. This guidance was written prior to the february 27, 1997 implementation of fdas good guidance practices, ggps. 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. Fda often sees no data, speaks no data, hears no data. Figure 1 substantial equivalence decision flow chart. 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. When does your device raise different questions of safety and. Evaluating substantial equivalence in premarket notifications.