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FDA Issues a Public Message Regarding Drugs of Abuse Tests
(posted June 13, 2005)
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
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