Practical Regulatory Affairs 2020 - US FDA Medical Devices

Introduction to the Practical Regulatory Affairs course and background.

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!

Use the link provided in Lecture 3 to navigate the eCFR and answer questions related to various Parts and Sections. Remember, Medical Devices are covered by the 800 series Parts, i.e. Part 800 to Part 898.

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

Learn how to classify a device in the US and become familiar with the Product Classification database.

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 6.

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 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

We explore the potential outcomes of a traditional 510(k) and the post-submission process.

Learn about the device registration and listing requirements with the FDA, and why this is an important step.

We present a brief overview of the current hot topic, Emergency Use Authorizations (EUA) in the context of the Covid-19 pandemic.

Some final resources are provided here which can also be useful in preparing FAD regulatory submissions. Thank you for completing this course!