FDA Letter
FDA Issues a Public Message Regarding
Drugs of Abuse Tests
(posted June 13, 2005)
Office of In Vitro Diagnostic Device Evaluation and Safety
FDA is working to address consumer confusion about tests used by businesses and consumers that are intended to screen for drugs of abuse like cocaine, marijuana, opiates, PCP, or methamphetamine.
Some companies in the market have stated that FDA clearance is not required for such tests. In fact, FDA has regulations that address premarket review of these screening tests. FDA review of screening tests intended to detect the presence of a drug of abuse involves an evaluation of both performance data and labeling. FDA reviews performance data to assure that in the hands of the intended user (whether a laboratory worker, a trained non-laboratory health care worker, or a lay user) the assay meets current standards for accuracy and reliability. FDA reviews proposed labeling to help assure that intended users can understand the instructions for use and that the labeling conveys other important information, including the importance of confirmatory testing when the results of the screening test are positive.
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. Manufacturers of tests with FDA approval or clearance have provided FDA with data to assure that their tests generate reliable results for the specimens being tested. If consumers are unsure whether a particular test has undergone FDA premarket review, they may search FDA’s database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
Consumers and businesses are advised to access the following FDA database, which includes data summaries provided by companies and recent review decision summaries posted by FDA:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?IVDProducts=on
Original Article
http://www.fda.gov/cdrh/oivd/letters/061305-doat.html