Hi everyone, I’m Steve with Dahlia Health and in this edition of our “Be Enlightened” series, we’re going to talk about FDA certification.
The light therapy market is filled with claims about FDA clearance. Unfortunately, it has created a lot of fear and uncertainty about the importance of this rating.
The FDA is most commonly known for regulating and approving pharmaceuticals. If they believe the manufacturer's research was done correctly and the results are safe, they will authorize them to sell the compound. Now, I’ve been through this process and it took nearly 4 years of clinical trials before the FDA was willing to reinstate a drug that had already been on the market for over 20 years. They don’t take their responsibility lightly. It’s a tough process and when something is FDA Approved it means something.
When it comes to medical devices, however, things are a little different. The process isn’t the same as they are for pharmaceuticals and that causes some confusion. The FDA uses a risk-based, tiered approach for regulating medical devices.
High risk devices are Class 3 - and those are things like heart valves or pacemakers and usually relate to items that are inserted inside a patient's body. These require FDA approval before they can be used outside clinical trials. Again, for Class 3 devices, the FDA is highly involved in reviewing test results from the manufacturer.
Medium risk devices are Class 2 and these are devices like powered wheelchairs, catheter tubing and even pregnancy kits. They are considered “FDA cleared,” which means the manufacturer's advertising matches what the device says it’s going to do.
Low risk devices are Class 1. According to the FDA, nearly half of all devices fall into this category and 95% of them are exempt from any review. The FDA does not inspect these devices and only checks to make sure manufacturers are not making ANY claims. It’s the same way they treat vitamins and supplements because they are low risk. The FDA considers light therapy devices to have a low risk of harm and they classify them in the same group as an electric blanket. The FDA has not evaluated anything. Examples of class 1 devices are elastic bandages, exam gloves, tongue depressors and electric blankets.
So what does all this mean? It means that when a red light therapy company is touting being FDA cleared, it’s building confidence that really doesn’t mean anything. It’s selling based on fear instead of results.
Dahlia is not currently listing our devices with the FDA. Sure, we could also register as a ‘warming blanking’ for $2800 a year, but it wouldn't help clients or clinicians. The FDA has not examined the device or treatment process and therefore, there are no additional protections for doctors or clinics. Insurance requirements and premiums should also remain the same. And, once someone registers their device, they can’t incorporate new research, clinical trials or simple improvements without starting over.
As a company that is pushing to improve the treatment process and the safety of our systems, Dahlia’s goal is to advance light therapy, not freeze it in time.
Dahlia’s focus is on certifications that protect you and your clients from risk. That’s why Dahlia systems are Medical Grade, our Smart Pads use sensors and we monitor every session. When learn something new, we can improve our treatment process in a matter of minutes, because we’re connected and our updates are always free.
I’m Steve with Dahlia Health. Be Enlightened.