On June 13, 2005, the FDA issued a public message addressing the need for drug tests used by businesses and consumers to be FDA-cleared.

The FDA advisory clarified prior misinformation in this area stating, “Some companies in the market have stated that FDA clearance is not required for such tests.  In fact, FDA has regulations that address pre-market review of these screening tests.” (The FDA had previously promulgated regulations 21 CFR 809.40 and 21 CFR 864.3260 requiring tests performed in the home, insurance, sports or workplace setting utilize screening tests that have been “… approved, cleared or otherwise recognized by the Food and Drug Administration as accurate and reliable for the testing of such specimens …")

In its message, the FDA cautioned that, “Tests that are not cleared by FDA may not meet current laboratory standards.  When FDA has not reviewed a test product, consumers and businesses cannot have the same assurance that the results of that test are correct as with an FDA-cleared test.”

The FDA advised businesses and other consumers to check for tests that have been reviewed by the FDA by searching the FDA database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

The full text of the FDA release can be found on the FDA website at http://www.fda.gov/cdrh/oivd/letters/061305-doat.html