“FDA Approved” Is Not the Same As “FDA Approved” (and Why the Difference Matters)

Companies love to twist the truth to make it look like their product is better than it really is, and one way they do this with certain medical products is to make it look like the FDA was instrumental in their conclusion. To the market. But just because a health-related device is “FDA-approved,” that doesn’t necessarily mean the FDA has looked into it or decided it actually works. And if something is “registered” or “recognised” by the FDA, this is an even bigger stretch.

FDA approved

The approval, from the point of view of the FDA, is official and serious. The Food and Drug Administration (FDA) approves prescription and over-the-counter drugs, Class III medical devices (those that have the potential to kill or seriously harm you), and certain other items such as vaccines and antibody therapy.

The approval process varies from category to category, but in general, manufacturers must provide data to support the safety and efficacy of their product. It takes a lot of time (and a lot of work and money) to go through this process.

Associated with approval is an “Emergency Use Authorized” or EUA status. This appointment is temporary and the application process is faster to use in cases where there is an advantage to being faster than the full approval period. For example, all COVID-19 vaccines were made available under the EUA for the first time.

approved by the Food and Drug Administration

With regard to medical devices, they can be divided into three classes . Class III is the type that is most heavily regulated. This includes things implanted in the body, and things that can literally decide between life and death, such as pacemakers. These devices must be approved.

Class I and II devices do not go through a rigorous approval process. Instead, they may be “FDA approved.” Class II includes powered wheelchairs, pregnancy tests, and items such as syringes. Finally, Class I devices are fairly simple items that cannot cause harm if misused, such as bandages. There are also Class I devices that can be sold without any presale documents, such as some thermometers and bedpans.

So when a company tells you that their device is “FDA approved,” they often try to give you the impression that the FDA has scrutinized their device and found it to be effective. But when you look at it, don’t be surprised if the device is a Class I device, which is essentially rated “yes, probably won’t harm people.”

FDA registered and certified

Other terms are just as suspicious. The FDA does not “register” or “certify” medical devices . Some businesses need to register with the FDA in order to be able to make or sell medical devices, but that doesn’t mean that everything they make is FDA-approved, approved, or whatever. The FDA also “recognises” the standards , but this does not mean that every product using a recognized standard has been reviewed by the FDA itself.

If you want to know if something has actually been approved or cleared by the FDA, here is their medical device search page and drug search page so you can check it out for yourself.

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