In today’s video, we talk about when healthcare products require a 510(k) to enter the market as an FDA-regulated medical device.

Hi, I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients just like you, navigate healthcare and FDA legal issues so you can launch or grow and scale your healthcare business.

You’ve got a product you’re selling that you made or that someone else made or manufactured and you or they say it treats this and cures that.  The machine has been selling, there are all sorts of customer testimonials letting people know how great this device is and encouraging everyone to buy it and use it.  I bought, my X went away; she bought, her Z disappeared.  Revenue is rolling in and you’re helping people, right?

There’s one glitch.  If you have a mechanical thing, let’s call it a device, and you claim that it treats or cures or mitigates a condition, then FDA is going to say that it’s a medical device.  So, you have an unregulated medical device on the market, subjecting you to all sorts of penalties once the enforcement authorities find out about what you’re doing.

There are many products like this out on the market.  This device sends light here, that one sends electromagnetic waves or frequencies there.

The Federal Trade Commission, FTC, which works in tandem with FDA, recently brought an enforcement action (because it doesn’t like these kinds of devices). The company promoted “alternative” treatments for cancer (especially bad).  When you make claims about cancer or coronavirus, these claims come to the front of the enforcement line.  In this case, FDA alleged that the company did not have adequate substantiation for their claims—meaning, they couldn’t prove what they said the product did.

So, what did the FTC do? They barred the company from making the unsubstantiated claims and from promoting those or similar products.

In a nutshell, game over. When you have a medical device, you have to find a regulatory pathway to market.  The more complex and risky devices require a PMA, which is premarket approval.  Some devices are exempt.  And most will require a 510(k), which means that they are substantially equivalent to a product that is already on the market.

FDA finds substantial equivalence where the new device has the same intended use and same technological characteristics of the first device, which we call the “predicate” device; and there’s alternative definition involving safety and efficacy.

So, you need a 510(k) when you first introduce the device to market; or when you market an existing product for a different intended use; or when modifying an existing device in a way that could significantly alter safety or effectiveness.

Thanks for watching. Please contact us with questions. We have helped hundreds and hundreds of healthcare industry clients just like you build their dream.  We look forward to working with you on your journey to success!