Investigational Use: Laboratory Developed Tests FAQs
A: Even though FDA has generally expected compliance with Investigational Use requirements for LDTs, we have included compliance with investigational use requirements for IVDs offered as LDTs in stage 2 in recognition that there has been some confusion about our enforcement approach in this area. Note that investigations of diagnostic devices are exempt from most part 812 requirements, provided that certain labeling requirements are met and the testing:
- is noninvasive,
- does not require an invasive sampling procedure that presents significant risk,
- does not by design or intention introduce energy into a subject, and
- is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure (§ 812.2(c)(3)).
Requirements under 21 CFR parts 50 and 56, relating to IRB approval and informed consent, generally apply to these studies.