Introduction:
FDA regulates and reviews drugs of abuse tests before they can be sold to consumers or healthcare professional in the United States. In its review, the FDA evaluates the design and performance of tests and sample collection systems to help ensure that they produce accurate results. The FDA also reviews the test instructions and package inserts to help ensure that the end users can understand how to perform the tests easily and successfully.
The information on this webpage may be helpful to anyone who performs drugs of abuse testing, including consumers, employers, or trained medical professionals. In addition, the manufacturers of these tests may also be interested in the types of data typically submitted for FDA review.
Resources:
FDA maintains a website called Device Advice that provides information on many aspects of tests that are regulated by FDA, including drugs of abuse tests. Within this website you may want to refer to the section entitled Overview of IVD Regulation.
For information specific to drugs of abuse, please refer to the following:
Drugs of Abuse (Collection Kit)
- navigate to: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm
- Search by 510(k) number, manufacturer’s name (Applicant Name), or name of the test (Device Name), or perform a very general search of many different drug test devices by selecting “Toxicology” in the drop-down menu under the section called “Panel.”
- Select particular tests in the “Device” column, and then “Decision Summary”
