In today’s video, we’ll help you further understand some of the important FDA rules around medical devices.

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 wellness and FDA legal issues and launch, or continue to scale, their health and wellness product or service.

Normally, we help medical device clients at the early phase, which is when they are first launching and trying to decide whether they even have a medical device that is regulated as such by FDA.  So here are some key legal rules in this early phase of medical device.

In general, FDA may classify a given health product as one of the following: (1) a food or dietary supplement; (2) a drug; (3) a medical device; (4) a radiation-emitting product; (5) a vaccine, blood or biologic; (6) an animal & veterinary product; (7) a cosmetic; or (8) a tobacco product.

While these various kinds of products have different statutory definitions, FDA gives some examples to clarify use.  For example, drugs you might think a prescription and non-prescription drugs; for medical devices -tongue depressors, biologics, vaccines and blood products.

Classification depends in large part on intended use—i.e., the way in which FDA can reasonably conclude, based on the product labeling (which is everything), that the manufacturer intends the product to be used a certain way. “Labeling” means not only the label on the box, but also any written, printed or graphic material accompanying the product (this includes the website and social media site).

Today, again we’re just talking about medical devices.  The key difference between a medical device on one hand, and, a drug on the other, is this:

If the product achieves its primary intended purpose through chemical action within or on the body and is metabolized by the body, it will likely either be deemed a human drug or a biological product, like an aspirin or vaccine.

All medical devices are subject under FDA rules, to establishment registration and medical device listing; quality system regulation; labeling requirements; medical device reporting; and other controls.  So, the first thing you need to know is “Do I even have a medical device?” because that’s a lot of regulations.

Then, after that, you need to know whether you have a Class 1 device, which is the lowest risk, Class 3, which is the highest, or Class 2 which is in between.  Examples of Class I devices are enema kits and elastic bandages.  Examples of Class 2 devices are powered wheelchairs.

The next important rule is that unless the medical device is “exempt,” then the device either requires Premarket Approval (also known as PMA), or, must be “substantially equivalent” to what is called a “predicate device,” and thus “cleared.”

The process of getting “cleared” by showing “substantial equivalence” to a “predicate device” requires submitting what is known as a “510(k)” submission to FDA.  Most Class 2 devices have to be cleared, while most Class 3 devices must be approved through a PMA.

Examples of exempt devices include manual stethoscopes, mercury thermometers, powered heating pads, and bedpans – things you use every day or might be used in hospital every day.  But still, the manufacturer has to register their establishment and list their product with FDA.

So as you can see, once you have a medical device, a lot is involved, so the easiest and most fun route is to determine that your product is likely to be a general wellness product, and thus is not subject to a medical device regulation in the first place.

We have other blogs in our website that talk about general wellness products, but what I want to say is, if the product is an “instrument, apparatus … machine…” which, among other things, is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, then that’s a definition of a medical device.

We covered a lot ground here, thank you for watching. Please come to us with your questions, click on the link below, cohenhealthcarelaw.com/contact, to send us a message or book an appointment. Here’s to the success of your healthcare venture, we truly look forward to connecting with you again very soon.