510(k) Submissions: Your Path to the US Medical Device Market

Why Should You Attend:

This webinar will provide the tools and understanding you will need for a successful 510(k) submission. It will cover how to develop a submission strategy, and how to complete the component parts of a 510(k) submission. It will address the different types of 510(k) submissions, and when to utilize each type of submission. We will discuss the principle of substantial equivalence, how to identify a suitable predicate device, and how to effectively demonstrate equivalence. A critical part of the submission process is responding to FDA questions; this webinar will provide you with proven responses to speed your path to market. Attending this session will help you avoid the most common pitfalls in 510(k) submissions and avoid costly delays in your product approvals.

All functional groups who have product development and approval responsibility or need to understand the basics of product approvals should attend.

Areas Covered in the Seminar:

• Overview of the Medical Device Approval Regulations
• Types of 510(k) pathways
• How to identify a predicate device
• Defining the Indented Use
• Making the case for substantial equivalence
• Device Labeling and Instructions for Use
• When to submit a 510(k) for device changes
• How to address requests for additional information
• How to avoid a not-substantially equivalent (NSE) determination
• How to obtain the broadest approval possible

Who Will Benefit:

• Regulatory Affairs
• Quality Assurance
• Compliance
• Research and development
• Quality Engineering
• Risk Managers
• Executive Management
• Controllers
• Risk Management
• Supply Chain Managers

Instructor Profile:

Chris Cook, PE, RAC, is a licensed professional engineer with over 10 years of global regulatory affairs experience. Mr. Cook is the Managing Director of 4Point Global Solutions, a consulting firm providing commercialization and compliance services to emerging and established medical device companies. Mr. Cook has been responsible for regulatory compliance for multinational corporations, such as, Stryker Corporation, Straits Orthopedics, and BIOTRONIK. He specializes in Customs, Commerce, and ITAR compliance assessments, executive awareness training, export and import classification guidance, supply chain security reviews and C-TPAT certification.

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