SCI — Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule Class N
FDA product code SCI covers "Ivd Offered As Ldt, Not An Ldt Or 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
- SCI
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Unknown
- Implant
- No
Definition
In vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that are not designed, manufactured, and used within a single laboratory, are within the scope of the phaseout policy and are not subject to a targeted enforcement discretion policy described in the preamble to the LDT Final Rule (89 FR 37286).