Medical Device Commercialization Overview

Developing a Regulatory Strategy

Will you be able to get your device approved?

To give you confidence that you will be able to ultimately market and sell the medical device you are developing, you must devise a strategy via which you can convince the applicable regulatory bodies that your product should be approved. The benchmark regulations are those of the Food and Drug Administration (FDA) in the United States. Other countries and regions such as the European Union have their own regulations, but if FDA approval is granted, approval from other authorities can usually be obtained. The overview provided herein is from the FDA perspective.

The regulatory strategy will be developed to provide the quickest and most cost-effective path to market. The process begins by establishing in what class the product is likely to fall – class I, class II or class III (classes refer to the risk to humans: class I devices pose little risk, class III devices could threaten life if a device failure occurs). The regulatory burden is heavier the higher the class, so correctly defining the product’s class will impact the type and extent of product testing that will be required and, hence, the level of design and development investment that can be anticipated.

After class, the regulatory strategy will consider whether or not there is an
established “predicate” device that has already been approved and marketed. If your product is deemed to be “substantially equivalent” to an existing device, you can seek approval by filing a premarket notification 510(k). If there is no predicate device, you will need to pursue the more onerous route of premarket approval (PMA). This is an expensive option that requires significant clinical trial studies, so it’s best to be prepared for this at the outset if there’s a possibility you will need to follow this route. The regulatory pathway can have a significant impact on the economic viability of your idea.

(Note: 510(k) and PMA are the most common, but there are other pathways available, depending on characteristics of the device. If there is no predicate but the device is low-risk, you might be able to use the “De Novo” pathway, which is the simplest. You might also be able to seek a humanitarian device exemption (HDE), a custom device exemption (CDE), Product Development Protocol (PDP), or Compassionate Use Provision).

Regulatory expertise is not one that Forma claims. However, we can partner with or refer you to a regulatory specialist.