Ldt, Unmet Need Within An Integrated Healthcare System
SCF · Not classified · Unknown
Classification
FDA Product Code
SCF
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
Laboratory developed tests (LDTs) manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system as described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286).