Originally Published IVD Technology
March 2004
INDUSTRY NEWS
FDA’s new guidance on drug tests |
FDA has issued a revised draft guidance on data and labeling requirements in
premarket notification submissions for drugs of abuse screening tests. This new
document supersedes and updates two previous guidances that were published in
2000.
The tests covered by the draft guidance include screening tests for
amphetamines, cocaine, methamphetamines, opiates, marijuana, and phencyclidine
(PCP).
The two previously issued guidance documents elicited some concerns from the IVD
industry. In particular, these documents stated that FDA would expect the same
type of information in premarket notification submissions for all drugs-of-abuse
screening tests. In the new revised draft guidance, the agency has clarified
that the data requirements in premarket submissions for drug screening tests
will depend on whether the tests are intended to be used in a laboratory
setting, in the workplace or other repetitive testing sites, or at home.
“For example, if a test is intended for use in a laboratory setting, we
recommend that the data provided in [the] submission be based on use of the test
by laboratory professionals, healthcare professionals, or trained staff,” says
the draft guidance. “For a test intended for occasional testing of individual
subjects by untrained users (e.g., home users), the data should be based on use
by untrained users. Similarly, if a test is intended for workplace or other
repetitive testing sites (outside of laboratories), [manufacturers] should
provide data reflecting the intended use, the use setting, and the likely
end-users.”
The IVD industry was also concerned about how the two previous guidance
documents included recommendations to bundle the costs of screening with the
costs of confirmatory testing.
“We are now clarifying that bundling was not and is not required. We recognize
that measures other than bundling these costs, such as clear and accurate
labeling, may help mitigate the risk of inaccurate test results, says the draft
guidance.”
In addition, FDA has taken steps toward more-effective enforcement in the
marketing of drugs-of-abuse testing products. The agency sent letters to four
companies that market sample collection kits for drugs-of-abuse testing. The
companies that received these letters were Avitar Inc. (Canton, MA), Medimpex
United Inc. (Feasterville, PA), Northwest Toxicology (Salt Lake
City), and Omega Laboratories Inc. (Mogadore, OH). These firms each sell
systems intended to test hair samples for drugs of abuse. In the letters, FDA
advised these companies that their tests used on collected samples have not been
cleared, approved, or otherwise recognized as accurate and reliable by
FDA.
The draft guidance may be accessed via the FDA Web site at www.fda.gov/ohrms/dockets/98FR/2003d-0522-gdl0001.doc.
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