You may also want to know that FDA may take action against an unapproved
device in intrastate commerce if that product contains components shipped
across state lines. In general if you are going to make an IVD for commercial
distribution you should consider the approval process.
In article <3u0v2c$ea4_001 at kiehl.cts.com>
Bryan Kiehl <b3748 at cts.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
> >> on humans?
> >> Thanks for the info.
> >> Jay Rothstein, Ph.D.
> If test kits are sold interstate (accross state lines) by a commercial
> company and are intended to be used for human diagnosis, then they do need
> some form of FDA review. If this is your intent, PCR is carefully regulated at
> FDA. I suggest that you call the office for small manufacturers. If needed, I
> could provide the number. This office is quite imformative.
>> It is not always clear what is needed if a lab performs a test method
> developed in-house. Today this is not typically under the review of the FDA,
> but reimbursement is a different matter. Additionally, medically liability is
> the concern of the kit manufacturer, laboratory and clinician and not usually
> related to FDA reviews.
>> Another problem you may also need to consider is liscensed used of PCR from