Intro to Medical Device Submission: 510(k)s, PMAs and Exemptions

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Course Director

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Course Fee

$2150.00 Regular Registration

$1950.00 Early Bird Pricing (Register 30 Days in Advance)

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Course Description

Geared for experienced medical device professionals and those new to the industry, this 15-hour medical device regulatory strategy seminar is designed for those who need a better understanding of the requirements for bringing medical devices to market in the United States.


Navigating this complex regulatory maze requires a strategic understanding of how the U.S. Food and Drug Administration (FDA) evaluates safety and efficacy.


This comprehensive 510(k) and premarket approval (PMA) medical device submission training covers important regulatory requirements and concepts through case study discussions of real products from a variety of clinical specialties. We move beyond theory to explore strategies for using regulation as a competitive advantage.

What This Course Covers

Participants will learn about:


Choosing the Right Path: 510(k), PMA or De Novo?


All medical device pathways to market are presented with a discussion of the advantages and challenges of each, including:

  • 510(k): Discover how to successfully argue equivalence to a predicate device in a 510(k) submission and avoid common not substantially equivalent (NSE) pitfalls. This pathway requires demonstrating that your device is as safe and effective as an already-cleared predicate, making predicate selection and comparison strategy critical to success.
  • PMA: Our PMA medical device course covers the extensive clinical data and manufacturing controls required for Class III devices. This comprehensive approach prepares teams for the most demanding FDA pathway, including clinical trial design, statistical analysis requirements and quality system documentation.
  • Specialized pathways: Explore alternative pathways, such as the De Novo and humanitarian device exemptions (HDE) process, for novel technologies that do not fit traditional molds. These specialized routes provide options for breakthrough devices or devices addressing rare conditions, each with unique requirements and strategic considerations.
  • Exemptions: Understand when a device truly qualifies for Class I or Class II exemptions to save time and resources. Proper exemption classification can eliminate the need for premarket submissions entirely, but requires careful analysis of device characteristics and regulatory definitions to ensure compliance.


Strategic Regulatory Planning


This seminar emphasizes early life cycle planning. You will learn to perform accurate device classification and regulatory submission assessments, which are critical for setting realistic timelines and budgets. We also cover how to build a robust FDA device clearance pathway strategy that aligns with your business goals. This ensures you do not spend millions on clinical trials when a less burdensome pathway exists.


Future-Proofing Your Regulatory Knowledge


Multiple examples of products on the market, under development, and on the drawing board, including videos, are presented in an interactive format. The seminar concludes with a look at the regulatory challenges for the future of the medical device industry, including combination products, tissue engineering and nanotechnology.


Interactive Case Studies and Application


Using case studies and medical device submissions, course participants will learn to communicate more effectively with regulatory professionals and the FDA. You will understand how regulation impacts medical device development to get products to market quickly and efficiently and to avoid problems before they occur.


Our goal is to turn regulatory compliance from a burden into a strategic asset. By the end of this course, you will be equipped to lead your team through the FDA submission process with confidence, minimizing the risk of costly "refuse to accept" (RTA) decisions.


Regulatory professionals at Terumo, Guerbet, DemeTECH and other medical device companies worldwide have relied on this training to navigate FDA submissions with confidence.

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Additional Course Information

  • Learning Objectives

    Upon completion of this course, attendees will have an understanding of the framework for FDA submission regulations and an approach on how to construct a submission. An appropriate submission strategy is necessary to legally manufacture a product in the U.S. market. 


    The course focuses on how a company's product situation should be evaluated to determine the correct interpretation of the submission requirements. Emphasis will be placed not only on regulatory aspects, but on the overall medical device product development strategy and environment. Creating an effective submission strategy will help your company avoid spending unnecessary time and money by avoiding an inappropriate path.


    Exercises and presentations from the FDA will be used to reinforce the key concepts from the course presentation. Attendees will receive extensive course notes that can serve as reference material after the course is completed.

  • Agenda


    Overview and Introduction

    • What is “regulatory logic” and how can we use it to our advantage?
    • What is and is not a regulated medical device?
    • How do we “design” or label (i.e., stated claims vs. inferred/implied claims)?
    • How can we “advertise” off-label use?
    • What is a general wellness device?
    • What is a competitive regulatory strategy (i.e., how can I use regulation as a barrier to entry to my competition)?

    Classification

    • What is the medical device classification system?
    • Why do we have a classification system? Why is it important?
    • How do I determine classification?
    • Can I change the classification?
    • How can I use classification to my advantage?
    • How does classification vary in other parts of the world?

    Pathways to Market

    • What are the seven major pathways to market? Compare and contrast:
    1. Premarket Notification a.k.a. 510k
    2. Premarket Approval (PMA)
    3. Product Development Protocol (PDP)
    4. de Novo
    5. Humanitarian Device Exemption (HDE)
    6. Custom Device Exemption (CDE)
    7. Expanded Access Program (EAP)
    • What are the advantages and disadvantages of each?
    • Which do I choose and when?
    • Must I use only one? Can I mix and match?

    Submission Statistics

    • What are the average review times?
    • Where can I find the most current statistics?
    • How do I beat the averages?
    • What can I do to expedite the process?

    Pre-Market Notification or (510k)

    • What is the Pre-Market Notification (PMN) a.k.a. 510k?
    • How can I use the 510k to my advantage?
    • What does substantial equivalence really mean?
    • Why are 75% of 510 (ks) rejected and how do I avoid being in the majority?
    • What types of 510(k’s) exist and how do I choose?
    • What are the two most important components of a successful 510(k)?
    • When and how can I use the split- and multiple predicate strategies safely and effectively?
    • Why is the 510k so controversial?
    • What is predicate creep?
    • If I change my device, must I tell the FDA (special 510(k) vs. letter-to-file)?
    • What is the future of the 510(k)?

    Premarket Approval (PMA)

    • Where does the PMA fit in the medical device universe?
    • Why are 89% of PMA’s rejected and how do I avoid being one of them?
    • How does the 510(k) compare to the PMA? Can I do both?
    • When is an IDE ‘required’ and when is it not (i.e., SR vs. NSR)?
    • What types of PMA’s exist and how do I choose?
    • What goes into a successful PMA?
    • When do I need a clinical trial and how do I design one?
    • Key steps

    De Novo Pathway

    • What is the De Novo, and how does it compare to the 510(k)?
    • Why is the De Novo the fastest-growing pathway to market in the U.S.?
    • How can I use the De Novo to my competitive advantage?

    Communication With FDA: The Pre-Submission Process

    • When and how should I communicate with the FDA?
    • What is a pre-sub and should we use it?
    • What is a successful pre-sub and why are most not successful?
    • How early should we talk to the FDA?
    • What should we include in the pre-submission?
    • Should we meet in person? How do we prepare?
    • What happens after the pre-submission? Are the results binding?

    Wrap Up and Look to the Future

    • What are the regulatory challenges of 3D printing, combination products, tissue engineering and biomedical nanotechnology?
    • Where can I find additional information?

    Bonus Topics


    The following topics are discussed throughout the course:

    • How do I integrate regulatory strategy and reimbursement strategy?
    • What goes into an international regulatory strategy?
    • How does a risk mitigation strategy compare to a risk management plan?
    • What is regulatory risk and how do I factor it into my regulatory strategy?
    • How can I use guidance documents to my competitive advantage?
    • What is usability and where does it fit into regulatory submissions?
    • What’s the difference between writing a regulatory submission and designing a regulatory submission?

  • Testimonial

    "I had a great experience with this course and thoroughly enjoyed the approach to fundamental case studies. It provided a clear and practical overview of medical device classification, the 510(k) process, and PMA submissions. I would highly recommend this course to anyone looking to deepen their understanding of regulatory pathways in the medical device industry."

    Vishwa P., Regulatory Affairs Specialist, DemeTECH


    "This course is meticulously designed to cover essential topics, case studies, and discussions, providing a comprehensive understanding of the topic. The materials provided by CfPIE prior to the course helped me to closely follow the course director who presented a variety of case studies, each uniquely addressing different topics, scenarios, and situations relevant to regulatory affairs. These case studies significantly enhanced my understanding of the subject matter. At the outset of the training, he promised to teach how to think not what to think. Well, he certainly succeeded in doing so.”

    Zakia A., Senior Regulatory Affairs Specialist, Guerbet


    "Very informative with helpful advice derived from real-life experiences.  Lots of practical advice with stories from actual examples."

    Jiwan M., Manager, Living Tree (Korea)


    "Thank you so much for taking the time to teach the course and being passionate about what you do. Your passion changed the way I see Regulatory matter of fact I think I like Regulatory more now than I did before."

    Kimberly J., RA Specialist, Terumo


    "This have been one of the most helpful courses I have taken. It covered all expected topics and gave me a lot of real-world examples. The knowledge of the instructor and the cases of study presented were the best part of the course.” 

    Claudia C., QA/RA Specialist, DemeTECH



FAQs

  • Does the course go beyond submission information for the US market?

    No. The course covers FDA's regulations which govern the US market only.

  • What materials come with the course?

    A course notebook is provided that contains the slides that are presented, publicly available reference materials from FDA and other entities, class exercises, and example documents.

  • Are there particular types of medical devices emphasized?

    The course necessarily covers a broad range of medical devices. Class I, II, and III medical devices are all discussed as are the different means to get various types of medical devices to market.

  • Does the course provide guidance on how to write -510k or PMA applications?

    The course does not provide in-depth evaluation of important aspects such as style, format, level of detail, and other aspects that can only come from experience gained in the medical device industry or potentially looking at other application examples. However, application contents, regulatory background, categorizing, and classifying devices is discussed in depth. How to access FDA's available real world application examples is discussed.

Registrant Information:

Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.