What statistical methods does the FDA mandate we use to identify quality issues? 1.57K viewsOctober 10, 2022Medical Device 0 Sam Smith11.38K October 16, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted October 16, 2020 0 Comments Spread the loveThe FDA does not mandate the use of any specific statistical algorithm. The only requirement is that you prove that whatever method you have chosen to use is capable of identifying quality issues from the data you monitor. Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login