Industries: Medical Device

Intro to Medical Device Submission - 510(k)s, PMAs & Exemptions

Course Director: Michael Drues, Ph.D.

Course Fee: $2150.00 Regular Registration / $1950.00 Early Bird (30 Days in Advance)

PLEASE NOTE:  Early Registration Discount is not available for El Paso, TX session - Course held in partnership with MCA Foundation and Discounts have already been applied.

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

Geared for both experienced medical device professionals as well as those new to the industry, this seminar is designed specifically for those who need a better understanding of the regulatory requirements necessary to bring medical devices to market in the US.  This 510(k), PMAs and exemptions submission course discusses important regulatory requirements and concepts using case study discussions of real products from a variety of clinical specialties.  Strategies for using regulation as a competitive advantage are also discussed.

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

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

Day One

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 labeling (i.e., stated claims vs. inferred/implied claims)?
  • How can we “advertise” off-label use?
  • What is a general wellness device?
  • What is 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 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:
    • Premarket Notification a.k.a. 510k
    • Premarket Approval (PMA)
    • Product Development Protocol (PDP)
    • de Novo
    • Humanitarian Device Exemption (HDE)
    • Custom Device Exemption (CDE)
    • 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 (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 510ks rejected and how do I avoid being in the majority?
  • What types of 510k’s exist and how do I choose?
  • What are the two most important components of a successful 510k?
  • 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 FDA (special 510k vs. letter-to-file)?
  • What is the future of the 510k?

Day Two

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 510k 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 510k?
  • Why is the de novo the fastest growing pathway to market in the US?
  • 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 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 FDA?
  • What do we need to include/should we include in the pre-sub?
  • Should we meet in person? How do we prepare?
  • What happens after the pre-sub? Are the results binding?

Wrap up and look to the future

  • What are the regulatory challenges of 3-D 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 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 vs. designing a regulatory submission?

Wrap-up

References

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 US market. The course focuses on how a company's product situation needs to be evaluated in order 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 be used as reference material once the course is completed.

Frequently Asked Questions

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.