Ivd Offered As Ldt, Not An Ldt Or Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule
This product code covers IVDs offered as LDTs that are not designed, manufactured, and used within a single laboratory, fall within the scope of the LDT Final Rule phaseout policy, and are not subject to a targeted enforcement discretion policy as described in the LDT Final Rule preamble (89 FR 37286). The device class is FDA Not Classified (N), with product code SCI, reviewed by the Clinical Chemistry panel, and no regulation number or medical specialty is assigned. These tests are expected to come into full FDA compliance over time under the phaseout schedule.
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Basic Information
- Product Code
- SCI
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- CH
- Submission Type
- 7
Device Characteristics
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).
Unclassified Reason
6