In this 510(k) submission process webinar attendees will learn the different types of 510(k)s, 21 required elements in the traditional 510(k) and how are they addressed and documented. Also attendees will learn software/firmware requirements, De Novo submission for obtaining marketing clearance for medical devices in the U.S.
The FDA holds companies responsible for filing new 510(k)s when new products are to be marketed in the U.S., or when existing products and/or their Indications for Use are changed.
What are the 21 mandatory elements?
How is Substantial Equivalence determined, proved, documented?
What should be included, and what should only be referenced.
What new concerns need to be addressed now?
How can companies make such determinations?
Which is better, a Summary or a Statement?
What approaches are required for product changes; for software/firmware changes; for process changes?
What about software 'in-' or 'as-product'?
How does ISO 14971 Risk Management and IEC 62366-1 Use Engineering/Human Factors fit into the 510(k) process?
How to maximize the 510(k) compilation process against scarce resources.
Why Should You Attend:
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process - for Class 2 devices. The U.S. FDA mandates that the traditional 510(k) submission address 21 basic requirements. The 'Special' and 'Abbreviated' 510(k)s must also address them, but in different ways.The FDA holds companies responsible for filing new 510(k)s when new products are to be marketed in the U.S., or when existing products and/or their Indications for Use are changed.
What are the 21 mandatory elements?
How is Substantial Equivalence determined, proved, documented?
What should be included, and what should only be referenced.
What new concerns need to be addressed now?
How can companies make such determinations?
Which is better, a Summary or a Statement?
What approaches are required for product changes; for software/firmware changes; for process changes?
What about software 'in-' or 'as-product'?
How does ISO 14971 Risk Management and IEC 62366-1 Use Engineering/Human Factors fit into the 510(k) process?
How to maximize the 510(k) compilation process against scarce resources.
Areas Covered in the Webinar:
- Basic U.S. FDA's expectations and requirements for the 510(k) submission
- The Three Types of 510(k)s and Their Uses
- The 21 Required Elements in the 510(k), and How Documented
- Finding, Proving and Documenting (formats for) Substantial Equivalence
- Addressing Product 'With-' or 'As-software' Issues
- The 'Statement' or The 'Summary' - which?
- Documenting 'Hazards Analysis', the MAUDE Database, Human Factors
- The Declarations
- U.S. FDA Device Clearance Process
Who Will Benefit:
- Senior and middle management.
- Quality Assurance
- Regulatory Affairs
- R&D
- Engineering
- Staff personnel
- Sales and Marketing
- Operations/Production
Course Provider
John E Lincoln,
