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FDA's Revised 510(k) Process: The Medical Device Professional's Guide to Successfully Preparing 510(k) Submissions and Regulatory Compliance
This medical device 510(k) training will help you understand the basics of 510(k) submissions and discuss how to develop and execute an approval strategy ensuring the fastest possible path to 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 utilize each type of submission. We will discuss the principle of substantially 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 session will provide you with proven responses to speed your path to market.
Attending this webinar will help you avoid the most comment pitfalls of 510(k) submissions and avoid costly delays in your product approvals.
Areas Covered in the Webinar:
- 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:
All functional groups who have product development and approval responsibility or need to understand the basics of product approvals should attend.
- Regulatory Affairs
- Quality Assurance
- Research and development
- Quality Engineering
- Risk Managers
- Executive Management
- Risk Management
- Supply Chain Managers
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 as 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.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
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