What Regulatory, Quality & Compliance Professionals Need to Know Webinar Oct. 21, 2020



FDA’s Plan for Modernizing the 510(k) Pathway:

What Regulatory, Quality & Compliance Professionals Need to Know

An FDAnews Webinar

Wednesday, Oct. 21, 2020, 1:30 p.m.-3:00 p.m. EDT


If one is developing a medical device in the United States, the FDA’s proposed changes to the 510(k) clearance pathway will probably apply. Are you ready for these adjustments?

This FDAnews webinar on the FDA’s Plan for Modernizing the 510(k) Pathway on Oct. 21 can get one there.

During this virtual conversation, gain insights into the FDA’s plans for updates to these important procedures and requirements, along with their effects on the regulatory process for most medical devices. We’ll talk about best practices, common mistakes manufacturers make and the agency’s expectations around 510(k) submissions.

Medical device regulatory affairs expert Mary Vater will share the ways the process is being modernized by the FDA, including advances in technology, safety and the capabilities of this new generation of devices. She will discuss the best ways to navigate the 510(k) process — considering the updated safety and performance criteria, the difficulties of obtaining clearances, the benefits these changes have for the public and what one should anticipate for future submissions.

During this webinar, we will cover:

● Changes to the 510(k) Process

     a. Implications for companies who choose predicates cleared over 10 years


     b. Public identification of companies

     c. Identifying suitable predicate devices

     d. Moving beyond premarket comparisons

     e. Understanding and using third-party reviewers

● Common Adverse Events in Product Classification

     a. Selecting a predicate with a clean history

● Dealing with New Challenges

     a. Possibility of additional testing to reflect post-market information

     b. How the FDA is addressing changing biocompatibility requirements

     c. Issues around reprocessed single-use devices

● Creating and Executing a Test Plan

     a. Identifying relevant standards and guidance

     b. Considering most recently cleared devices within the product code

● Best Practices

     a. Timing for filing a pre-submission

     b. Questions to ask during a meeting

     c. Staying current with the latest FDA guidance and enforcement policies

Changes are coming to the FDA’s 510(k) pathway — and if one develops medical devices in the U.S., one can’t avoid the adjustments. Learn how to best navigate these differences and successfully move a product through the process of submission.

Interested in registering multiple sites?

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally

to learn about our special multisite discount.

Webinar Details:

FDA’s Plan for Modernizing the 510(k) Pathway:

What Regulatory, Quality & Compliance Professionals Need to Know

An FDAnews Webinar

Wednesday, Oct. 21, 2020, 1:30 p.m.-3:00 p.m. EDT

https://www.fdanews.com/510kpathwa y


$287 per site

Easy Ways to Register:

Online: https://www.fdanews.com/510kpathway

By phone: 888.838.5578 or 703.538.7600

About FDAnews:

FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews’ print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA’s complex and ever-changing regulations

Share article on social media or email:

Leave a Reply