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Compliance In Focus
Posted by Jacqui Lingler on Wed, Mar 27, 2013

Home Use Tests - Are they Medical Devices?

Concerned about your cholesterol? Trying to track your ovulation and hoping to get pregnant?Home Use Tests - Are they Medical Devices? Want to drug test your teenager? There are at home use tests for these questions and more. For around $20.00 dollars you can avoid long doctor’s office waits, submitting claims to the insurance company and discussing potentially embarrassing topics with your primary care physician. But, are these home use tests consider medical devices and therefore subject to the same rigor of clinical trials to confirm accuracy and safety?

According to FDC Act, Section 201, a Device is defined as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, which is:”

  • Intended for the use in the diagnosis of disease… in cure, mitigation, treatment, or prevention of disease
  • Intended to affect the structure of any function of the body not achieved through chemical action or being metabolized

On the FDA’s website, in vitro diagnostic products and test kits are included under Products and Medical Procedures, therefore, under 21 CFR 812 may require clinical trials based on risk stratification.

Many home use kits are approved by the FDA, however, the agency is warning consumers not to use unapproved diagnostic kits that have been marketed nationwide via the Internet by Globus Media, Montreal, Canada. These illegal kits are labeled as:

  • Rapid HIV Test Kit
  • Rapid Syphilis Test Kit
  • One Step Cassette Style Cocaine, Marijuana, and Amphetamine Test
  • Rapid Dengue Fever Test
  • One Step Midstream Style HCG Urine (Home)
  • Pregnancy Test

A full list of approved tests and kits can be found on the FDA’s website.

Although the FDA identifies the benefits of home use test, the agency advises the consumer to take precautions when using home use test and reminds the public that they should not replace periodic visits to your doctor.

Have you searched the FDA’s website for approved home use test? Which products approved by the FDA are most surprising to you? Were you aware that the FDA approved the first at home diagnostic HIV test in July 2012?

Photo Credit: Wyscan

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Topics: Medical Devices, Home Use Tests, FDA


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