Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule
This product code covers laboratory developed tests (LDTs) that fall within the scope of the LDT Final Rule phaseout policy and are not subject to any targeted enforcement discretion policy described in section V.B of the LDT Final Rule preamble (89 FR 37286), representing the general population of LDTs that will require full FDA premarket review over time. The device class is FDA Not Classified (N), with product code SCJ, reviewed by the Clinical Chemistry panel, and no regulation number or medical specialty is assigned.
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Basic Information
- Product Code
- SCJ
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- CH
- Submission Type
- 7
Device Characteristics
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).
Unclassified Reason
6