If you’ve ever researched medical devices, drugs, skincare treatments, or aesthetic procedures, you’ve probably seen the terms “FDA cleared” and “FDA approved” thrown around. While they may sound similar, they have very different meanings. Understanding the distinction is crucial for med spa owners, practitioners, and consumers alike.
What Does FDA Cleared Mean?
U.S. Food and Drug Administration (“FDA”) clearance applies to medical devices that are deemed substantially equivalent to an existing, legally marketed device. This process falls under the 510(k) premarket notification pathway.
To obtain FDA clearance, a device manufacturer must demonstrate that their device is as safe and effective as a previously approved or cleared device (called a predicate device). This means the product does not require extensive clinical trials, as long as it functions similarly to something already on the market.
Examples of FDA-Cleared Devices in Aesthetics:
- laser hair removal devices
- certain types of radiofrequency skin-tightening systems
- microneedling pens (if classified as a medical device)
Key Takeaway: FDA clearance does not mean the device has undergone rigorous clinical trials—it simply means the device is similar to something that has already been reviewed and cleared by the FDA.
What Does FDA Approved Mean?
FDA approval is a more stringent process required for drugs and high-risk medical devices. This process involves substantial clinical trials to prove safety and efficacy. Products that require FDA approval go through the Premarket Approval (“PMA”) process, which involves extensive research, human trials, and data review.
For a product to be FDA approved, manufacturers must provide significant scientific evidence demonstrating that it works as intended, is safe for use, and has a favorable risk-benefit profile.
Examples of FDA-Approved Products in Aesthetics:
- dermal fillers (e.g., Juvederm, Restylane)
- botulinum toxin injections (e.g., Botox, Dysport, Xeomin)
- prescription skincare products (e.g., Tretinoin, Latisse)
Key Takeaway: FDA approval signifies that a product has undergone rigorous testing and clinical trials to confirm its safety and effectiveness.
Why Does This Matter for Med Spa Owners?
Understanding the difference between FDA clearance and FDA approval is essential for med spa owners and practitioners. Here’s why:
- Marketing Compliance: Using the wrong term in advertising can mislead customers and lead to regulatory trouble.
- Patient Safety: Clients may assume a device or treatment is FDA approved when it’s only FDA cleared, leading to unrealistic expectations.
- Legal Protection: Misrepresenting FDA status in promotions could result in fines or legal action.
Final Thoughts
Before investing in a new device or treatment for your med spa, make sure you understand whether it is FDA cleared or FDA approved. This distinction helps ensure compliance, protects clients, and maintains your credibility in the industry.
Have questions about FDA compliance in your med spa? Contact Lengea Law to ensure your practice is following all necessary regulations!