Description

Successfully navigating the 510(k) submission process is a crucial step for Class II medical device manufacturers aiming to secure FDA clearance. Mastering this regulatory pathway can make a decisive impact on a product’s success in the U.S. market.

This comprehensive webinar will walk you through the essentials of assembling a compliant 510(k) submission. It will cover the critical elements the FDA looks for, common mistakes that can cause costly delays, and proven strategies to ensure a smoother path to approval.

Attendees will learn:

How to identify and justify a proper predicate device to demonstrate substantial equivalence.
Key components and documentation required for submission — including safety and performance testing, labeling, and software validation requirements.
The importance of maintaining a strong quality system, even though it is not directly submitted in a 510(k).
Insights into FDA’s new e-Star submission tool, designed to streamline and simplify the process.
How to avoid common pitfalls that often lead to rejections and how to proactively mitigate risks.

By the end of the session, participants will be equipped with a practical roadmap to efficiently prepare their 510(k) submissions, reduce regulatory challenges, and accelerate market entry.

Topics to Be Covered:

Detailed Overview of the 510(k) Process
Predicate Device Selection & Demonstrating Substantial Equivalence
Documentation, Testing, and Compliance Expectations
Navigating the e-Star Digital Submission Format
Common Reasons for FDA Rejections and How to Avoid Them
Best Practices for a Faster Approval Process

Background

The 510(k) process is a vital regulatory requirement for medical device companies intending to market their products in the U.S. It allows new devices to demonstrate substantial equivalence to already cleared products, offering a more accessible route compared to the Premarket Approval (PMA) process. Amid growing regulatory complexities and evolving submission requirements, clear and actionable guidance is essential. This webinar delivers crucial knowledge and strategies for achieving successful, compliant 510(k) submissions.

Why You Should Attend

Submitting a 510(k) can be a complex and intimidating task fraught with potential setbacks. Companies often face challenges in choosing the right predicate, conducting required tests, structuring their submissions, and keeping up with regulatory updates — all of which can result in costly delays.

During this informative webinar, you will:

Gain a clear, step-by-step understanding of the 510(k) submission journey.
Learn about common pitfalls that cause rejections — and how to prevent them.
Receive guidance on selecting an appropriate predicate device.
Get expert advice on fulfilling testing, labeling, and software validation expectations.
Understand the benefits of using the e-Star digital submission process.
Discover best practices to expedite submission and approval timelines.

Ideal for start-ups, regulatory professionals, quality managers, and product developers, this session will empower you with the tools needed to confidently manage your 510(k) submissions.

Who Should Attend:

Regulatory Affairs Specialists and Managers
Quality Assurance Professionals
Medical Device Manufacturers
R&D Engineers and Product Developers
Compliance Officers
Medical Device Start-up Founders
Regulatory Compliance Consultants

Speaker: Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA, is the President and Principal of Regulatory Doctor. A renowned expert in FDA regulatory and compliance matters, Dr. Lim is a sought-after speaker at industry forums and conferences. He has a strong track record of assisting the pharmaceutical and medical device industries with regulatory, clinical, and compliance challenges, and he has also advised investment professionals on regulatory risk assessment and decision-making.