Instructor :
John E Lincoln

Webinar ID:
12455

The US FDA has implemented crucial changes to modernize the 510(k) clearance pathway—but many companies are struggling to adapt, leading to delays in marketing clearance.

This urgency was reaffirmed last year in the FDA’s Medical Device Safety Action Plan and its Draft Guidance Document. These updates are a top priority for the FDA, aiming to transform how a 510(k) submission can accelerate medical advancements for patients.

What You’ll Learn:

• • Master Comparative Testing: Understand how to demonstrate substantial equivalence through comparative testing against predicate devices—a crucial element for a successful submission.
  • Embrace Beneficial Iteration: Discover the FDA’s emphasis on innovation with “beneficial iteration”, and learn why adopting this approach can fast-track your submission.
  • Avoid Costly Delays: Learn how to meet the FDA’s expectations to ensure a quicker review cycle. Understand the risks of failing to comply, including delays or an RTA (Refuse to Accept) decision.
  • Optimize Your Submission: Get actionable insights on presenting the right information in the Traditional 510(k) format to enhance your competitive position in the market.

By attending this 90-minute webinar, you’ll gain a clear understanding of the FDA’s evolving requirements for the 510(k) process, helping you accelerate time-to-market for your medical devices. Prepare your submissions with confidence, stay compliant, and drive innovation—all while keeping up with the latest regulatory trends.

This course is perfect for medical device manufacturers, regulatory affairs professionals, and compliance managers looking to navigate the updated 510(k) process and gain a competitive edge.

Join us and transform the way you approach the FDA’s 510(k) submissions!

The US FDA has implemented crucial changes to modernize the 510(k) clearance pathway—but many companies are struggling to adapt, leading to delays in marketing clearance.

This urgency was reaffirmed last year in the FDA’s Medical Device Safety Action Plan and its Draft Guidance Document. These updates are a top priority for the FDA, aiming to transform how a 510(k) submission can accelerate medical advancements for patients.

What You’ll Learn:

• • Master Comparative Testing: Understand how to demonstrate substantial equivalence through comparative testing against predicate devices—a crucial element for a successful submission.
  • Embrace Beneficial Iteration: Discover the FDA’s emphasis on innovation with “beneficial iteration”, and learn why adopting this approach can fast-track your submission.
  • Avoid Costly Delays: Learn how to meet the FDA’s expectations to ensure a quicker review cycle. Understand the risks of failing to comply, including delays or an RTA (Refuse to Accept) decision.
  • Optimize Your Submission: Get actionable insights on presenting the right information in the Traditional 510(k) format to enhance your competitive position in the market.

By attending this 90-minute webinar, you’ll gain a clear understanding of the FDA’s evolving requirements for the 510(k) process, helping you accelerate time-to-market for your medical devices. Prepare your submissions with confidence, stay compliant, and drive innovation—all while keeping up with the latest regulatory trends.

This course is perfect for medical device manufacturers, regulatory affairs professionals, and compliance managers looking to navigate the updated 510(k) process and gain a competitive edge.

Join us and transform the way you approach the FDA’s 510(k) submissions!

This 90-minute webinar is designed to help you understand the new FDA expectations for 510(k) submissions and how to successfully align with them.

The 510(k) pathway is used for the majority of medical devices seeking FDA clearance, and with recent updates, it’s critical to stay informed to avoid costly delays.

Key Takeaways:

• • Stay Ahead of Regulatory Changes: Get the latest insights on the FDA’s updated requirements, including details from the Release Statement, Draft Guidance, and the Medical Device Safety Action Plan.
  • Accelerate Your 510(k) Review Process: Learn how to implement the right comparative testing strategies to demonstrate substantial equivalence to predicate devices, ensuring a faster review cycle.
  • Avoid Common Pitfalls: Understand what the FDA expects to see in a 510(k) submission and avoid mistakes that could result in unnecessary delays or a Refuse to Accept (RTA) decision.
  • Gain a Competitive Edge: Master the concept of “beneficial iteration” to make strategic improvements to your device, positioning your company for greater success in the market.
  • Improve Submission Quality: Discover best practices for presenting the required information in the Traditional 510(k) format, making your submission more comprehensive and compelling.

Don’t miss this opportunity to refine your 510(k) strategy, boost your regulatory expertise, and accelerate the clearance process for your medical devices. Register now and turn these updates into a competitive advantage for your organization!

Enroll Now!

This 90-minute webinar is designed to help you understand the new FDA expectations for 510(k) submissions and how to successfully align with them.

The 510(k) pathway is used for the majority of medical devices seeking FDA clearance, and with recent updates, it’s critical to stay informed to avoid costly delays.

Key Takeaways:

• • Stay Ahead of Regulatory Changes: Get the latest insights on the FDA’s updated requirements, including details from the Release Statement, Draft Guidance, and the Medical Device Safety Action Plan.
  • Accelerate Your 510(k) Review Process: Learn how to implement the right comparative testing strategies to demonstrate substantial equivalence to predicate devices, ensuring a faster review cycle.
  • Avoid Common Pitfalls: Understand what the FDA expects to see in a 510(k) submission and avoid mistakes that could result in unnecessary delays or a Refuse to Accept (RTA) decision.
  • Gain a Competitive Edge: Master the concept of “beneficial iteration” to make strategic improvements to your device, positioning your company for greater success in the market.
  • Improve Submission Quality: Discover best practices for presenting the required information in the Traditional 510(k) format, making your submission more comprehensive and compelling.

Don’t miss this opportunity to refine your 510(k) strategy, boost your regulatory expertise, and accelerate the clearance process for your medical devices. Register now and turn these updates into a competitive advantage for your organization!

Enroll Now!

• • Basic Understanding of U.S. FDA’s Expectations for the 510(k) Process: Gain a solid foundation in the fundamentals of the 510(k) pathway and what the FDA looks for in a successful submission.
  • FDA’s Perspective and Rationale: Understand the Agency’s “thinking” behind the modernization of the 510(k) clearance pathway to better align your submissions with their strategic priorities.
  • FDA Commissioner’s Statement on Modernizing the 510(k) Pathway: Explore key highlights from the FDA Commissioner’s statement, emphasizing the need for modernization and its impact on industry practices.
  • Medical Device Safety Action Plan: Learn about the latest updates from the Medical Device Safety Action Plan and how it ties into enhancing patient safety and accelerating device approvals.
  • Safer Technologies Program for Medical Devices: Review the Draft Guidance Document for the Safer Technologies Program (STeP) and understand how it can expedite clearance for low-risk medical devices.
  • The Concept of “Beneficial Iteration”: Discover what the FDA means by “beneficial iteration”, its significance in the 510(k) process, and how embracing this concept can enhance your device’s market potential.
  • Implementation Strategies in Line with Current FDA Guidelines: Learn practical strategies for implementing the latest FDA guidelines and requirements into your 510(k) submission for optimal results.
  • Step-by-Step Guide to the 510(k) Review Process: Understand what needs to be done before, during, and after the 510(k) review process to avoid delays and ensure a smooth submission experience.
  • Key Pre-Submission, Submission, and Post-Submission Actions: Identify the critical actions required at each stage, including preparing your submission, navigating the review cycle, and managing post-submission communications with the FDA.

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.

• • Basic Understanding of U.S. FDA’s Expectations for the 510(k) Process: Gain a solid foundation in the fundamentals of the 510(k) pathway and what the FDA looks for in a successful submission.
  • FDA’s Perspective and Rationale: Understand the Agency’s “thinking” behind the modernization of the 510(k) clearance pathway to better align your submissions with their strategic priorities.
  • FDA Commissioner’s Statement on Modernizing the 510(k) Pathway: Explore key highlights from the FDA Commissioner’s statement, emphasizing the need for modernization and its impact on industry practices.
  • Medical Device Safety Action Plan: Learn about the latest updates from the Medical Device Safety Action Plan and how it ties into enhancing patient safety and accelerating device approvals.
  • Safer Technologies Program for Medical Devices: Review the Draft Guidance Document for the Safer Technologies Program (STeP) and understand how it can expedite clearance for low-risk medical devices.
  • The Concept of “Beneficial Iteration”: Discover what the FDA means by “beneficial iteration”, its significance in the 510(k) process, and how embracing this concept can enhance your device’s market potential.
  • Implementation Strategies in Line with Current FDA Guidelines: Learn practical strategies for implementing the latest FDA guidelines and requirements into your 510(k) submission for optimal results.
  • Step-by-Step Guide to the 510(k) Review Process: Understand what needs to be done before, during, and after the 510(k) review process to avoid delays and ensure a smooth submission experience.
  • Key Pre-Submission, Submission, and Post-Submission Actions: Identify the critical actions required at each stage, including preparing your submission, navigating the review cycle, and managing post-submission communications with the FDA.

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.

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

• • Regulatory Affairs Managers Seeking To Stay Compliant With FDA’s Updated Requirements: Learn how to navigate the new 510(k) standards and avoid delays.
  • Medical Device Manufacturers Aiming To Accelerate Time-To-Market: Gain insights into faster 510(k) review processes and avoid costly setbacks.
  • Product Development Teams Focused On Innovation And Market Competitiveness: Understand how “beneficial iteration” can give your products a competitive edge.
  • Compliance Managers Looking To Ensure Submission Accuracy And Minimize Risks: Discover best practices for preparing comprehensive and compliant 510(k) submissions.
  • CEOs And Business Leaders Driving Strategic Decisions: Learn how the modernized 510(k) pathway impacts your market strategy and opportunities.
  • Quality Assurance Professionals Focused On Meeting Regulatory Standards: Understand the critical testing and documentation needed for a smooth 510(k) process.
  • Project Managers Overseeing 510(k) Submissions And Regulatory Projects: Get a clear roadmap of submission requirements to streamline project timelines.
  • Clinical Affairs Specialists Developing Effective Testing And Comparison Protocols: Learn what the FDA expects in comparative testing to meet substantial equivalence standards.
  • Start-Up Founders In The MedTech Space: Accelerate your path to market by mastering FDA’s updated 510(k) process and guidelines.

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

• • Regulatory Affairs Managers Seeking To Stay Compliant With FDA’s Updated Requirements: Learn how to navigate the new 510(k) standards and avoid delays.
  • Medical Device Manufacturers Aiming To Accelerate Time-To-Market: Gain insights into faster 510(k) review processes and avoid costly setbacks.
  • Product Development Teams Focused On Innovation And Market Competitiveness: Understand how “beneficial iteration” can give your products a competitive edge.
  • Compliance Managers Looking To Ensure Submission Accuracy And Minimize Risks: Discover best practices for preparing comprehensive and compliant 510(k) submissions.
  • CEOs And Business Leaders Driving Strategic Decisions: Learn how the modernized 510(k) pathway impacts your market strategy and opportunities.
  • Quality Assurance Professionals Focused On Meeting Regulatory Standards: Understand the critical testing and documentation needed for a smooth 510(k) process.
  • Project Managers Overseeing 510(k) Submissions And Regulatory Projects: Get a clear roadmap of submission requirements to streamline project timelines.
  • Clinical Affairs Specialists Developing Effective Testing And Comparison Protocols: Learn what the FDA expects in comparative testing to meet substantial equivalence standards.
  • Start-Up Founders In The MedTech Space: Accelerate your path to market by mastering FDA’s updated 510(k) process and guidelines.