Be wary of claims that are “FDA registered” or “FDA certified.” Such phrases may imply that the product has been reviewed by the Food and Drug Administration. However, the first term simply means that the manufacturer has registered the facility in which the product is produced annually with FDA, not that the product has been approved or licensed by the agency. As for the second claim, FDA does not certify products or issue certificates of registration, making such a claim misleading, at the very least.
Search the FDA site. You can find out if a device is FDA approved by checking the device database, which means the company has demonstrated that the device is equivalent to products that the FDA has already carefully reviewed. You can similarly look for home medical tests, including some coronavirus home tests, in the FDA’s home tests database. Enter a term, such as “urinary tract infection,” in the name of the test or company and click “Search.”
Review tests for CLIA certification. For tests that you use at home and send back to a lab to have the results analyzed, such as genetic tests, check the label or online instructions to make sure the lab is “CLIA certified.” This means that the test meets federal quality standards and the lab undergoes routine testing before accepting human samples for testing. Think of this as a minimum requirement.
Consult your healthcare provider. They might be able to help you with your purchase considerations or know of easier, less expensive ways to get the answers you want to know. For example, your doctor might be able to prescribe a test to check your cholesterol levels rather than you having to buy one yourself. Or they might have specific recommendations for home monitoring devices. That way, you have peace of mind without having to shop around on your own.
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