Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule
SCJ · Not classified · Unknown
Classification
FDA Product Code
SCJ
Device class
Not classified
Regulation
—
Review panel
CH
Medical specialty
Unknown
Submission type
7
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
Laboratory developed tests (LDTs) within the scope of the phaseout policy and not subject to a targeted enforcement discretion policy described in section V.B of the preamble to the LDT Final Rule (89 FR 37286).