FDA approval is required to sell any in vitro diagnostic assay in the
United States. Assays are regulated as devices and fall into one of
three classes, I, II or III. The specific requirements for approval
depend on the class.
Hospital or commercial reference laboratories which perform patient
testing are regulated by the States and under Medicare per the Clinical
Laboratory Improvement Act - CLIA. CLIA is administered by the Health
Care Finance Administration -HCFA and agencies such as JCAH and CAP which
have "deemed status" to act on behalf of HCFA. CLIA and corresponding
State laws and regulations define the qualifications of lab directors and
technicians and the requirements for offering tests for human diagnosis.
Lab Directors may purchase FDA approved tests or in some cases may design
and validate tests themselves - referred to as "homebrews." Homebrews
are not regulated by the FDA, although that area is controversial and
Reimbursement is even more complicated with no one set of guidelines. In
general, whoever pays the bill decides what they are willing to pay or
not pay. Some insurers will pay for some "experimental" therapies or
test, others won't. You need to ask the particular insurance carrier what
their rules are.
If you are thinking of offering a test for use in human diagnosis, get
some solid advice from someone expert in the area before proceeding. You
can get yourself and your institution in a lot of trouble if you fall
outside of the regulations.
Disclaimer: I am not an attorney or even an expert in FDA regulatory
affairs. Please get advice from someone who is before offering any
On 10 Jul 1995 DjayR at aol.com wrote:
> Does anyone know if a newly developed PCR test needs FDA approval to get
> remimbursed from insurance companies? IF it is FDA approved and the test
> fails who is responsible? Is FDA approval required for all diagnostics tests
> on humans?
> Thanks for the info.
>> Jay Rothstein, Ph.D.