From owner-diagnostics@net.bio.net Tue Jul 11 23:00:00 1995 Newsgroups: bionet.diagnostics Path: biosci!bcm!cs.utexas.edu!howland.reston.ans.net!news.sprintlink.net!crash!kiehl From: b3748@cts.com (Bryan Kiehl) Subject: Re: FDA Questions Organization: CTSNET Date: Wed, 12 Jul 1995 16:59:56 GMT Message-ID: <3u0v2c$ea4_001@kiehl.cts.com> X-Newsreader: News Xpress Version 1.0 Beta #3 References: <950710143833_111729917@aol.com> Sender: news@crash.cts.com (news subsystem) Nntp-Posting-Host: kiehl.cts.com Lines: 26 >>> 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. >> 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 Roche. >> >> .