Instructor :
Charles H. Paul

Webinar ID:
8231

Did you know that 75% of first-time FDA 510(k) submissions are rejected? Even more striking, 85% of those rejections result from issues with substantial equivalence.

These numbers reveal just how complex and challenging the 510(k) submission process can be.

In this 90-minute interactive training, you’ll gain practical insights and expert strategies to confidently navigate the FDA’s rigorous 510(k) process and avoid the common mistakes that lead to costly delays and rejections.

Key Takeaways Include:

• • Understanding the three types of 510(k) submissions: Traditional, Special, and Abbreviated
  • Navigating the latest regulatory changes, including:
    • • FDA’s recognition of international standards now mandatory for 510(k) submissions
      • The requirement for a structured submission format with both paper and electronic copies
      • The Refuse-to-Accept (RTA) policy and how to ensure your submission meets the criteria
      • How submissions are subdivided among FDA reviewers, leading to closer scrutiny
      • Complying with specific test lab standards and documenting them effectively
      • Managing the Additional Information Required (AI) process, where the FDA requests more data

Led by Charles H. Paul, a seasoned regulatory consultant with over 20 years of experience, this course provides step-by-step guidance on identifying predicate devices, selecting the right submission method, and completing the submission process accurately for each type.

Equip yourself with the knowledge and tools needed to approach your next 510(k) submission with confidence.

Enroll Now!

Did you know that 75% of first-time FDA 510(k) submissions are rejected? Even more striking, 85% of those rejections result from issues with substantial equivalence.

These numbers reveal just how complex and challenging the 510(k) submission process can be.

In this 90-minute interactive training, you’ll gain practical insights and expert strategies to confidently navigate the FDA’s rigorous 510(k) process and avoid the common mistakes that lead to costly delays and rejections.

Key Takeaways Include:

• • Understanding the three types of 510(k) submissions: Traditional, Special, and Abbreviated
  • Navigating the latest regulatory changes, including:
    • • FDA’s recognition of international standards now mandatory for 510(k) submissions
      • The requirement for a structured submission format with both paper and electronic copies
      • The Refuse-to-Accept (RTA) policy and how to ensure your submission meets the criteria
      • How submissions are subdivided among FDA reviewers, leading to closer scrutiny
      • Complying with specific test lab standards and documenting them effectively
      • Managing the Additional Information Required (AI) process, where the FDA requests more data

Led by Charles H. Paul, a seasoned regulatory consultant with over 20 years of experience, this course provides step-by-step guidance on identifying predicate devices, selecting the right submission method, and completing the submission process accurately for each type.

Equip yourself with the knowledge and tools needed to approach your next 510(k) submission with confidence.

Enroll Now!

Submitting a 510(k) application isn’t just a regulatory requirement—it’s a strategic milestone that can make or break your product’s market timeline.

With increased scrutiny and evolving FDA standards, missteps in your submission can lead to costly rejections and months of delay.

This training offers practical, insider strategies to help you:

• • Increase your likelihood of first-time approval by understanding exactly what the FDA expects
  • Avoid preventable administrative pitfalls, including those flagged under the FDA’s Refuse-to-Accept (RTA) policy
  • Gain clarity on submission structure and content, reducing back-and-forth and speeding up the process
  • Build internal confidence in managing the submission process—from start to finish

Whether you’re leading regulatory submissions or supporting the process, this course equips you with the tools and knowledge to move forward with precision and confidence.

Register Today!

Submitting a 510(k) application isn’t just a regulatory requirement—it’s a strategic milestone that can make or break your product’s market timeline.

With increased scrutiny and evolving FDA standards, missteps in your submission can lead to costly rejections and months of delay.

This training offers practical, insider strategies to help you:

• • Increase your likelihood of first-time approval by understanding exactly what the FDA expects
  • Avoid preventable administrative pitfalls, including those flagged under the FDA’s Refuse-to-Accept (RTA) policy
  • Gain clarity on submission structure and content, reducing back-and-forth and speeding up the process
  • Build internal confidence in managing the submission process—from start to finish

Whether you’re leading regulatory submissions or supporting the process, this course equips you with the tools and knowledge to move forward with precision and confidence.

Register Today!

1. Introduction to the 510(k) Process

• • Understand the purpose and significance of 510(k) submissions
  • Overview of the FDA’s current regulatory landscape and review criteria

2. Predicate Devices: The Cornerstone of Your Submission

• • What is a predicate device and why it matters
  • How to identify and evaluate suitable predicate devices

3. Structuring a 510(k) Submission

• • Key components of a well-organized submission
  • Best practices for formatting and assembling documents

4. Deep Dive into Submission Types

• • Traditional 510(k) Submissions
    • • Required content and structure
      • When and why to use this submission type

• • Special 510(k) Submissions
    • • Key differences from the traditional route
      • Situations where this streamlined pathway applies

• • Abbreviated 510(k) Submissions
    • • Leveraging FDA-recognized standards
      • Criteria for selecting this route

5. Summary and Regulatory Insights

• • Understanding submission timing and strategic planning
  • Common pitfalls and how to avoid them
  • Navigating the Refuse-to-Accept (RTA) checklist and Additional Information (AI) requests

BONUS:

1. 1. PDF copy of the presentation handout for your future reference.
   2. Soft copy of the certificate of completion on request.
   3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

1. Introduction to the 510(k) Process

• • Understand the purpose and significance of 510(k) submissions
  • Overview of the FDA’s current regulatory landscape and review criteria

2. Predicate Devices: The Cornerstone of Your Submission

• • What is a predicate device and why it matters
  • How to identify and evaluate suitable predicate devices

3. Structuring a 510(k) Submission

• • Key components of a well-organized submission
  • Best practices for formatting and assembling documents

4. Deep Dive into Submission Types

• • Traditional 510(k) Submissions
    • • Required content and structure
      • When and why to use this submission type

• • Special 510(k) Submissions
    • • Key differences from the traditional route
      • Situations where this streamlined pathway applies

• • Abbreviated 510(k) Submissions
    • • Leveraging FDA-recognized standards
      • Criteria for selecting this route

5. Summary and Regulatory Insights

• • Understanding submission timing and strategic planning
  • Common pitfalls and how to avoid them
  • Navigating the Refuse-to-Accept (RTA) checklist and Additional Information (AI) requests

BONUS:

• 1. PDF copy of the presentation handout for your future reference.
  2. Soft copy of the certificate of completion on request.
  3. Q&A Session with the Presenter: Get your pressing questions answered verbally, via chat or email

The following benefits from watching this. Even better when done as a group!

• • Navigate The Complete FDA 510(k) Submission Process Confidently
  • Identify And Select Appropriate Predicate Devices For Submissions
  • Structure And Assemble A Compliant 510(k) Submission Package
  • Differentiate Between Traditional, Special, And Abbreviated Submission Types
  • Apply Best Practices For Meeting FDA’s Review Expectations
  • Avoid Common Administrative Pitfalls, Including RTA Policy Triggers
  • Respond Effectively To FDA’s Additional Information (AI) Requests
  • Leverage International Standards To Strengthen Submission Compliance

The following benefits from watching this. Even better when done as a group!

• • Navigate The Complete FDA 510(k) Submission Process Confidently
  • Identify And Select Appropriate Predicate Devices For Submissions
  • Structure And Assemble A Compliant 510(k) Submission Package
  • Differentiate Between Traditional, Special, And Abbreviated Submission Types
  • Apply Best Practices For Meeting FDA’s Review Expectations
  • Avoid Common Administrative Pitfalls, Including RTA Policy Triggers
  • Respond Effectively To FDA’s Additional Information (AI) Requests
  • Leverage International Standards To Strengthen Submission Compliance