All you need to know about the FDA regulations

With this guide, we will walk you through the main FDA regulations for bringing medical devices to market.

The introduction of medical products into any market always involves the need to comply with certain rules. The European market is regulated by the MDR, and the US market follows the guidelines of the FDA.

This US federal agency is responsible for controlling and supervising such matters as drugs, medical devices, food safety, veterinary products, and cosmetics. All this aims to protect human health and life, while also promoting novelties in the medical services sector.

As the FDA sets policies for the classification and distribution of medical devices in the US market, in this eBook we wanted to prepare you to fulfil them. Therefore, we took it upon ourselves to explain the rules for medical devices and their approval process.

How to determine if your product is a medical device?

First, we share knowledge about the FDA background, its criteria, and ways of defining products and software that are considered medical devices.

An introduction to the FDA’s regulations of medical devices.

Then we shed some light on requirements for medical devices, which include classification product codes and the understanding of the “Level of Concern” concept.

How are medical devices classified by the FDA?

Here we delve into the topic of the three classes to which medical devices can be assigned to, depending on their risk assessment. In this part, we also list examples of software as a medical device for each class.

How to get FDA approval for medical devices?

FDA software validation process.

Differences and similarities between FDA and EU MDR.

Lastly, we run a full comparison between the European MDR regulations, and the US market requirements imposed by the FDA.