Practical Regulatory Affairs 2025 - US FDA Medical Devices

A high-level overview of the US Food and Drug Administration, and their role in regulating medical devices in the US.

A brief overview of US Medical Device legislation, as outlined in the Code of Federal Regulations (CFR). We'll walk through the eCFR and learn how it is organized, and how to navigate the different legislation. Test your knowledge with a short quiz!

Learn about the definition of a medical device in the US, and potential exemptions from device status.

Walk through practical examples of device classification, including product code and regulation number using the Product Classification database and eCFR. Test your knowledge with three exercises of device classification.

We go through the answers and workflow for classification of the three devices presented in Lecture 5.

Introduction to the key regulatory pathways in the US: Pre-market Notification (510(k)), Pre-Market Approval (PMA) and De Novo submissions.

A high-level introduction to the well-known 510(k) process, and the key goals of this submission type

Learn about the concept of substantial equivalence to predicate devices, and how this idea forms the basis of a 510(k) submission

We explore the difference between "intended use" and "indications for use", present an example of this variation, and discuss why this is important to the concept of substantial equivalence.

We present two different strategies to practically identify potential predicate devices, using the various FDA databases at our disposal.

Learn how to evaluate potential predicate devices to see if they can be considered substantially equivalent to our device

We present an overview of different types of 510(k)s, as well as their general structure. Also present a brief example of using the FDA Guidance document search feature.

We explore the potential pathways in cases where a suitable product code could not be identified, including the 513(g) mechanism.

We learn about the De Novo submission, and why it was introduced as a potential regulatory pathway.

We examine the pro's and con's of the De Novo route, and touch upon some potential regulatory strategy that can be employed using this submission type.

We learn about the PMA, how it differs from a 510(k), and some of the key information that needs to be presented to the FDA

We discuss the difference between "FDA Cleared" and "FDA Approved", terms which are sometimes used interchangeably, though incorrectly.

We present a brief overview of the Quality System Requirements (FDA QSR), and explore potential exemptions to these requirements.

We present the costs and process associated with various FDA submission types