Drafting 510(k) Submissions Under New FDA Policies - 2012 & Beyond

Why Should You Attend:

FDA has initiated substantial changes to the Premarket Notification “510(k)” process that significantly increase the data and documentation requirements for Class II medical devices. Very few manufacturers are aware of the practical changes that will be needed during design control and 510(k) submission process to ensure lengthy and expensive delays do not occur for their new products.

The focus of this webinar is NOT on general theory of legal and regulatory compliance, but rather a practical ‘roll up your sleeves’ approach towards planning and implementing essential changes within your own company that will meet the FDA requirements for 510(k) cleared products. In this webinar, essential pragmatic methods and practical tools will be discussed in detail - techniques and procedures that you will be able to implement immediately to guide your teams and ensure compliance with the upcoming changes related to Class II and Class III product registration requirements.

The webinar will begin with a very brief, but comprehensive overview of the regulatory changes that have occurred over the past three years relating to the premarketing notification processes (per U.S. FD&C Act sec. 510(k)) applicable to Class II medical devices. However, the bulk of the presentation will focus on real world problems, and issues that can impede the regulatory submission review and clearance process.

 Free Handouts:

We will review and discuss three free template documents prepared by the presenter, an FDA Regulatory Attorney, and provided to each webinar participant:

• Corporate Policy for Compliance with FDA Changes to the Premarket Notification “FD&C Act sec. 510(k) Process”
• SOP on How to Prepare a 510(k) Submission to Meet FDA Requirements – 2012
• Compliance Checklist - 510(k) Submission – 2012