Why Are Some Products Not Meant to Be FDA Approved?
When it comes to products regulated by the FDA (U.S. Food and Drug Administration), particularly in skincare and medical devices like light therapy products, terms like "approved," "cleared," and "registered" each carry specific meanings that reflect different levels of FDA evaluation and oversight. Here’s a breakdown:
FDA Approved
"FDA approved" applies to high-risk products, such as prescription medications and Class III medical devices (like pacemakers or heart stents). Approval requires a thorough review process, including clinical trials, to ensure safety and effectiveness for the intended use.
- Examples: Prescription drugs and Class III medical devices, such as heart valves, that have undergone extensive testing and proven safe and effective for specific treatments.
FDA Cleared
"FDA cleared" is a designation specifically for medical devices, not for drugs, supplements, or cosmetics. This label indicates that a device poses moderate risk (usually Class II) and has been shown to be substantially equivalent in safety and effectiveness to an already marketed, legally available device. Clearance is appropriate for non-invasive, moderate-risk devices.
- Example: Light therapy devices, such as Celluma for acne or wrinkle treatment, are FDA cleared as Class II devices. This clearance demonstrates that they are comparable in safety and efficacy to similar devices already available on the market, as verified through the FDA’s substantial equivalence review process.
FDA Registered
“FDA registered” means that a company, facility, or establishment has registered its information with the FDA. Registration applies to businesses involved in manufacturing, packaging, processing, or storing food, drugs, or medical devices, allowing the FDA to monitor these locations for compliance.
- Example: A cosmetics company manufacturing lotions would register its facility with the FDA to comply with regulatory requirements. This registration simply means that the FDA is aware of the facility's existence, but it doesn’t mean that each individual product has been FDA approved or cleared.
Key Differences to Understand
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FDA Approval: Required for high-risk products intended for serious or invasive treatments, which must undergo rigorous clinical testing to prove safety and efficacy.
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FDA Clearance: Applies to moderate-risk, non-invasive devices (such as light therapy for acne) that show equivalence to already cleared devices without needing extensive new trials.
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FDA Registration: Involves registering a facility with the FDA but does not imply individual product evaluation or endorsement.
Verify FDA Claims
Consumers can use the FDA’s Establishment Registration and Device Listing database to verify whether a product is genuinely FDA cleared or approved like Celluma. For example, you can search a product or facility by entering its information in the FDA’s database here. This helps consumers verify if claims of FDA clearance are legitimate or possibly misleading.
Tips & Hacks
Important Note: If you see a home-use product being marketed as “FDA approved,” it’s a red flag, as this is unlikely for non-prescription, consumer devices. FDA approval is generally reserved for high-risk medical devices and drugs, so light therapy devices like Celluma should be FDA cleared, not approved.
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