In today’s video, we discuss medical devices and the basic information you need to know about them.

Many of our clients have asked us how they are supposed to know whether something is considered a medical device or not, and what kind of regulations apply to medical devices.

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We’ve advised over a thousand healthcare industry clients on healthcare and FDA legal issues. Today, I’m going to explain how medical devices are defined and what some of the key regulations are that they have to comply with. By the end of this video, you’ll know how to recognize something as a medical device and what that distinction can mean for a health and wellness business.

So to start, let’s consider the way medical devices are defined by the federal Food, Drug, & Cosmetic Act (“FDCA”). Specifically, we look to Section 201(h) which deals with the definition. There are more parts to it than we cover here but these are the most relevant ones. So the medical device can be an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory.

What qualifies it as a medical device is its intended use in “the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.”

Alternatively, it would qualify if it were intended to “affect the structure or any function of the body of man or other animals, “provided it doesn’t do this by chemical means, which would be entering drug territory.

And remember that medical devices are subject to a lot of requirements. Very broadly these include establishment registration and Medical Device listing, Quality System regulation, labeling requirements, Medical Device Reporting, premarket notification (unless exempt) or Premarket Approval, Reporting Corrections and Removals, and requirements for clinical studies of investigational devices.

These requirements can be onerous and costly, but it doesn’t have to be a nightmare either. Working with an experienced healthcare and FDA attorney can help you plan a business strategy for your medical device to better navigate these legal and regulatory hurdles.

Thanks for watching. Here’s to the success of your healthcare venture, we look forward to speaking with you soon.