Is LOINC-coding mandated by FDA for IVD tests? 1.28K viewsOctober 10, 2022FDA 0 Sam Smith11.38K October 12, 2020 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted October 12, 2020 0 Comments Spread the loveNo. LOINC, or any similar coding system for IVD tests, is voluntary and not required by FDA. FDA, however, strongly encourages the use of consensus standards for coding of IVD tests and specifically recognizes the utility of LOINC for this purpose. Spread the love You are viewing 1 out of 1 answers, click here to view all answers. Login
