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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  2. Medical Devices
  3. Products and Medical Procedures
  4. In Vitro Diagnostics
  5. Home Use Tests
  1. In Vitro Diagnostics

Home use tests allow you to test for some diseases or conditions at home. These tests are cost-effective, quick, and confidential. Home use tests can help:

  • detect possible health conditions when you have no symptoms, so that you can get early treatment and lower your chance of developing later complications (i.e. cholesterol testing, hepatitis testing).
  • detect specific conditions when there are no signs so that you can take immediate action (i.e. pregnancy testing).
  • monitor conditions to allow frequent changes in treatment (i.e. glucose testing to monitor blood sugar levels in diabetes).

Despite the benefits of home testing, you should take precautions when using home-use tests.

  • See your health care provider regularly. Home use tests are intended to help you with your health care, but they should not replace periodic visits to your doctor.
    • Most tests are best evaluated together with your medical history, a physical exam, and other testing.
    • Always see your doctor if you are feeling sick, are worried about a possible medical condition, or if the test instructions recommend you do so.
  • Always use new test strips that areauthorized for sale in the United States. The FDA has issued a safety communication warning about the risks of using previously owned test strips or test strips that are not authorized for sale in the U.S.

Approvals:

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