U.S. FDA’s Latest Requirements for the 510(k)
Presented by John Lincoln, EAS Independent Consultant.
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process, others are exempt, and some must go through the extremely costly, time consuming and rigorous PMA approval process. The FDA holds companies responsible for filing new 510(k)s, or IDEs / PMAs 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 steps and how are they documented? How is 510(k) vs PMA determined. What should be included, and what should only be referenced. What new concerns need to be addressed now, as a result of the FDA’s August 2010 510(k) study and resulting January 2011 Report? The 3 types of 510(k)s and when used. The 21 mandatory elements to be addressed. Tougher requirements. Changed requirements. Software “in-” or “as-product”? How does Product Risk Management fit into the submission process?
Topics covered include:
- Tougher Expectations / Requirements
- The 510(k) – Pre-market ‘notification’ and FDA Device Clearance
- Predicates and Substantial Equivalence
- Intended Use / Indications for Use
- The IDE – Investigational Device Exemption; IRB’s; Disclosures
- Clinicals – the ‘basics’
- The PMA – Pre-market Approval
- Resolving a “Wrong” Decision
About the Presenter
EAS Independent Consultant, John Lincoln, has worked with companies from start-ups to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. John has held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, he has prior experience in military, government, electronics, and aerospace. John has published numerous articles in peer reviewed journals, book chapters, conducted workshops and webinars worldwide. He is a graduate of UCLA.