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Validity : 27th Apr'24 to 07th May'24
The 510(k), IDE, Q-Sub, De Novo, and PMA Submission and Approval Process
- The 510(k) and its purpose.
- The 21 Required Elements in the 510(k) - A model
- Finding, Proving, and Documenting Substantial Equivalence
- Addressing Product "With-" or "As-software" Issues
- Documenting Device Risk
- The Declarations
- The Q-Sub, IDE, De Novo, and PMA submissions
- U.S. FDA Device Clearance Process
Overview of the webinar
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. 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, and documented? What about IDEs, De Novos, or PMAs? And how to initiate dialog with the agency under the Q-Submission program. What should be included, and what should only be referenced? What new concerns need to be addressed now? How can companies make such determinations? What approaches are required for product changes; for process changes? What about software "in-" or "as-product"? How does ISO 14971 Risk Management fit into the submission documentation process?
Who should attend?
Expectations for meaningful, results-driven device submissions and documented product development activities are increasing among the U.S. FDA, as well as similar expectations by regulatory agencies worldwide. Growing high-profile field problems indicate that design control and its effect on new/changed products and the submission review process is not as formal and rigorous as the FDA expects. How can a company maximize the data to prove compliance with the 21 FDA-defined requirements for a valid submission? For most companies, proactively addressing these concerns, spoken or unspoken, are not rocket science. Proactive implementation in current device submissions can minimize wasted resources, assist the FDA reviewer to clear the submission, speed up the entire process, and minimize the chance of unnecessary delays in the FDA's decision.
- Senior management
- Regulatory Affairs
- Quality Assurance
- Production
- R&D and Engineering
- All personnel involved in a U.S. FDA-regulated environment especially those involved in new product development, line extensions, and incremental product improvements, have to evaluate those changes to existing FDA-cleared / approved submissions, and then document their decisions in harmony with regulations.
Why should you attend?
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. In addition, the FDA Task Force has identified several problem areas with the existing medical device 510(k) process, leading to the growing push by the Agency to strengthen the 510(k) process. What can companies do in proactively addressing these issues, to "put the reviewer's mind at ease" when reviewing a 510(k)? How can we use a similar format and rationale for IDEs, De Novos, and even PMAs? Use of the Q-Sub to initiate dialog with the Agency.
Faculty - Mr.John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 40 years experience in U.S. FDA-regulated industries, 27 of which are as an independent consultant. John has worked with companies from start-up 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, CAPA systems and analysis. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, conducted workshops and webinars worldwide on CAPA, 510(k)s, risk analysis / management, FDA / GMP audits, validation, root cause analysis, and others. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.