Companies love to bend the truth to make it seem like their product is better than it is—and one way they do this with certain medical products is by making it sound like the FDA had a major role in bringing it to market. But if a health-related gadget is “FDA cleared,” that doesn’t necessarily mean the FDA studied it or decided that it actually works. And if something is FDA “registered” or “recognized,” that’s even more of a stretch.
FDA approved
Approval, in FDA terms, is official and serious. The FDA approves prescription and over-the-counter drugs, class III medical devices (the ones that could potentially kill or seriously harm you), and a few other items, such as vaccines and antibody therapies.
The approval process varies from category to category, but generally, manufacturers have to submit data showing their product is safe and effective. It takes a long time (and a lot of work and money) to go through this process.
Related to approval is the status of “emergency use authorized,” or EUA. This designation is temporary, and the application process is quicker, to be used in cases where there’s a benefit to acting faster than the full approval timeframe. COVID-19 vaccines, for example, were all first made available under an EUA.
FDA cleared
When it comes to medical devices, there are three classes. Class III is the type that’s most tightly regulated. It includes things that are implanted into the body, and things that can literally make a difference between life and death, like pacemakers. These devices need to be approved.
Class I and II devices don’t go through a rigorous approval process. Instead, they can be “FDA cleared.” Class II includes powered wheelchairs, pregnancy tests, and items like syringes. And finally, Class I devices are fairly simple items that have little potential for harm if they’re misused, like bandages. There are also Class I devices that can be marketed without any pre-market paperwork at all, like some thermometers and bedpans.
So when a company tells you that their device is “FDA cleared,” they’re often trying to give you the impression that the FDA scrutinized their device and found it to be effective. But when you look into it, don’t be surprised if the device is a Class I item that essentially got a judgment of “yep, probably won’t hurt people.”
FDA registered and certified
Other terms are similarly suspicious. The FDA does not “register” or “certify” medical devices. Some facilities need to register with the FDA to be able to manufacture or sell medical devices, but that doesn’t imply that everything they make is FDA-approved, cleared, or anything else. The FDA also “recognizes” standards, but that doesn’t mean that every product using a recognized standard was vetted by the FDA itself.
If you want to find out whether something has actually been approved or cleared by the FDA, here is their medical device lookup page and the drug lookup page so you can check for yourself.
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