Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule
SCE · Not classified · Unknown
Classification
FDA Product Code
SCE
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
Currently marketed in vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that were first marketed prior to May 6, 2024, and not modified following that date or not modified beyond the scope described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286).