Medical Devices

We are medical device industry regulatory experts

The consultants at Medical Devices and Pharma have decades of aggregated experience working with a variety of medical devices. That includes expert knowledge of regulations from the U.S. Food and Drug Administration (FDA), Health Canada (HC), the European Union (EU) and other global regulatory bodies. We offer current information about new and novel medical devices, device safety alerts, industry news, and enforcement actions like FDA warning letters. Our regulatory specialists can expertly compile, prepare, and submit regulatory submissions for regulatory marketing authorization, like an FDA 510(k) premarket submission.

What is a medical device?

The definition of a medical device encompasses a wide range of complexity and purposes, from a walking cane to an artificial heart. It can be a physical apparatus or something like software or a chemical reagent.

Regardless of its form or composition, a product is defined as a medical device if it is used to diagnose a medical issue; alleviate, prevent or minimize the risk of a medical problem; or to provide medical treatment.

The differences between medical devices and pharmaceuticals.

Is your product a medical device?

Let us answer your questions about your medical device product, from device classification and requirements to establishment registration and device listings and requirements you need to follow in order to market the product in the U.S. Click here to contact us.

The FDA defines a medical device as:

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is:

1. Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
2. Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
3. Intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and
4. Which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

The term “device” does not include software functions excluded pursuant to section 520(o). Source: “Is the Product a Medical Device?“

Pre-amendment and post-amendment devices

Devices are also identified as pre-amendment or post-amendment based on when they received FDA market clearance. This makes a difference for how a manufacturer can put a device on the U.S. market.

Pre-amendment devices were on the market prior to the enactment of the Medical Device Amendments (MDA) of the Food, Drug and Cosmetic Act on May 28, 1976. They do not require a premarket approval (PMA) or premarket notification (510(k)) submission prior to market entry. 

Post-amendment devices received marketing approval after the enactment of the MDA in 1976. Class III devices require the FDA approval of a PMA before the device can be sold on the market. Most class II and some class I devices require a 510(k) premarket notification submission to demonstrate that they are substantially equivalent to a medical device that is currently marketed in the U.S.