Table 3.

Differences in regulatory governance of diagnostic tests

Government agency via regulatory authority	CMS via CLIA program	FDA via code of regulations (21 CFR)
Has regulatory authority over…	Clinical laboratories	Medical device manufacturers
Intent of regulations	Ensure accurate test results are performed and delivered	Ensure safety and efficacy of marketed devices and tests distributed to laboratories
Scope of analytical validity	Single laboratory where test is performed	All laboratories that use the device/test as intended in device labeling
Regulates IVD test	Yes – through laboratory oversight	Yes – through device manufacturer oversight
Regulates LDTs	Yes – through laboratory oversight	No – FDA has exercised ‘enforcement discretion’* thus far, which may change in future

*Enforcement discretion is a form of regulation which allows the FDA to formally choose not to enforce the regulations. The FDA may decide to reverse this decision and regulate LDT in the future. CFR: Code of Federal Regulations, CMS: Centers for Medicare and Medicaid Services, CLIA: Clinical Laboratory Improvement Amendments, FDA: Food and Drug Administration, IVD: In vitro diagnostic, LDTs: Laboratory developed tests