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Practical Regulatory Affairs 2020 - US FDA Medical Devices

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Pubudi Silva

From the authors of the leading EU Medical Device Regulations course on Udemy, we now present Practical Regulatory Affairs 2020 for US FDA Medical Devices.

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From the authors of the leading EU Medical Device Regulations course on Udemy, we now present Practical Regulatory Affairs 2020 for US FDA Medical Devices.

The US is one of the worlds leading medical device markets, with a unique regulatory framework. Being able to navigate the US regulatory landscape is a crucial skill for anyone interested in working in regulatory affairs, or anyone looking to bring a device to market in the US. This course focuses on the practical application of regulatory tools and pathways available through the US FDA, using real-world examples and exercises to help you understand not only the regulations themselves, but how to effectively comply with them. Wherever possible, we provide you with relevant links and information from the FDA itself to guide your understanding in each module.

Written and developed by a group of Regulatory Affairs professionals currently working in industry, this course focuses on the most common issues and questions we receive from medical device manufacturers looking to enter the US market.

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What's inside

Learning objectives

  • Learn about us regulations for medical devices, and the role of the fda
  • Understand the various regulatory pathways available for medical devices in the us
  • Learn how to practically use the various fda tools and databases to determine the required regulatory route
  • Discover how to navigate the fda website to find more relevant information for specific devices

Syllabus

Pre-Market Approval (PMA)

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

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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!

Traffic lights

Read about what's good
what should give you pause
and possible dealbreakers
Introduces learners to working in regulatory affairs, a key field in medical device development
Helps students navigate the US regulatory landscape for medical devices
Takes a practical approach with emphasis on using FDA tools and pathways
Taught by professionals currently working in the medical device industry
Requires students to have some background knowledge in regulatory affairs or medical devices
Provides links and information from the FDA website for further exploration

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Reviews summary

Practical us fda medical device regulations

According to learners, this course offers a highly practical and clear introduction to US FDA medical device regulations. It is particularly praised for its focus on real-world application and hands-on exercises, such as navigating the eCFR and FDA databases, which students found to be a game-changer. Students consistently highlight the well-structured lectures and clear explanations of complex topics, making it an excellent resource for beginners or those new to regulatory affairs. While most feedback is overwhelmingly positive, some experienced professionals found certain sections to be somewhat basic. The course's provision of official FDA links are highly valued, reinforcing learning through helpful quizzes.
The course is logically organized and easy to comprehend.
"The instructors broke down complex FDA regulations into understandable, actionable steps."
"It's well-structured and easy to follow. The quizzes helped solidify my learning."
"The content is comprehensive, covering all essential regulatory pathways. The instructors' expertise shines through, making dry topics engaging."
"I learned so much about device classification and how to actually use the FDA tools."
Highly suitable for those new or transitioning into regulatory affairs.
"Absolutely invaluable for anyone working in or looking to enter medical device regulatory affairs."
"As a beginner, I found the explanations of 510(k), PMA, and De Novo pathways incredibly clear."
"It's structured logically and provides all the necessary links to FDA resources. Definitely a foundational course for this field."
"It largely covers basic concepts that I already know. While it could be good for someone completely new..."
Provides essential hands-on experience with FDA tools.
"The practical exercises using FDA databases (like the Product Classification database and eCFR) were a game-changer for me."
"This course clarifies the often-confusing world of FDA regulations. The exercises are effective, making sure you don't just passively listen but actively engage."
"It does a great job of walking you through the actual FDA websites and tools. For a general overview with a practical bent, it's very effective."
"I can now confidently navigate these resources. Highly recommend for its practical focus."
Some minor feedback regarding audio quality and course date.
"My only minor feedback would be about the audio quality in some of the older lectures; it was a bit muffled at times."
"I also noticed that the '2020' in the title made me question its currency, though I didn't spot anything definitively outdated."
May offer less new insight for seasoned professionals.
"For someone with some prior knowledge, certain introductory sections felt a bit slow, but overall, the course delivers on its promise."
"As an experienced regulatory professional, I found this course too superficial for my needs. It largely covers basic concepts that I already know."
"I was expecting more advanced strategies and complex case studies."
"It's a decent overview, but not as in-depth as I hoped for some topics."

Activities

Be better prepared before your course. Deepen your understanding during and after it. Supplement your coursework and achieve mastery of the topics covered in Practical Regulatory Affairs 2020 - US FDA Medical Devices with these activities:
Connect with experts in US regulatory affairs
Expand your network and gain access to valuable insights by connecting with experts in the field.
Show steps
  • Attend industry events
  • Join online communities related to US regulatory affairs
  • Reach out to experts directly via email or LinkedIn
Review the basics of US regulatory affairs
Review the key concepts of US regulatory affairs to ensure a strong foundation for the course.
Show steps
  • Review the FDA website
  • Read articles and blog posts about US regulatory affairs
  • Take a free online course on US regulatory affairs
Review the FDA Guidance documents
The FDA provides comprehensive guidance documents that can help you understand the regulatory requirements for medical devices. Reviewing these documents can help you to better understand the regulatory landscape and to prepare your submissions.
Show steps
  • Visit the FDA website and browse the available guidance documents
  • Choose a few guidance documents relevant to your product and read them carefully
  • Summarize the key requirements and recommendations in each guidance document
  • Use the information you have gathered to inform your regulatory strategy
Three other activities
Expand to see all activities and additional details
Show all six activities
Create a summary of the FDA regulatory pathways
Develop a deeper understanding of the FDA regulatory pathways by creating a summary of the key points.
Show steps
  • Review the FDA website and other resources
  • Identify the key points of each regulatory pathway
  • Write a summary of the FDA regulatory pathways
Develop a regulatory strategy for a hypothetical medical device
Apply your knowledge of US regulatory affairs to develop a regulatory strategy for a real-world scenario.
Browse courses on FDA
Show steps
  • Identify the target market for the medical device
  • Determine the regulatory pathway for the medical device
  • Develop a regulatory strategy for the medical device
  • Write a report summarizing the regulatory strategy
Answer questions about US regulatory affairs on a forum
Share your knowledge of US regulatory affairs by answering questions on a forum.
Show steps
  • Join a forum related to US regulatory affairs
  • Answer questions about US regulatory affairs

Career center

Learners who complete Practical Regulatory Affairs 2020 - US FDA Medical Devices will develop knowledge and skills that may be useful to these careers:

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Course image
Rating
4.4 Filled star Filled star Filled star Filled star Empty star
Effort
1.5 total hours
Via
Udemy
Instructor
Pubudi Silva
Language
English
Traffic lights
Read about what's good
what should give you pause
and possible dealbreakers
Introduces learners to working in regulatory affairs, a key field in medical device development
Helps students navigate the US regulatory landscape for medical devices
Takes a practical approach with emphasis on using FDA tools and pathways
Taught by professionals currently working in the medical device industry
Requires students to have some background knowledge in regulatory affairs or medical devices
Provides links and information from the FDA website for further exploration
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