SCJ — Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule Class N
FDA product code SCJ covers "Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- SCJ
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Unknown
- Implant
- No
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).