The U.S FDA requires that 21 basic elements be addressed in the traditional 510(k) submission. This can serve as a model for other submissions.
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, documented? What about IDE's, De Novo's or PMAs? And how to initiate dialog with theAgency 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?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 IDE's, De Novo's, and even PMAs. Use of the Q-Sub to initiate dialog with the Agency.Areas Covered in the Webinar:
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 world wide. Growing high-profile field problems indicate that design control and it’s effect on new/changed product 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 to 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 the entire process, and minimize the chance of unnecessary delays in the FDA's decision.
Principal, J E Lincoln and Associates
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 36 years’ experience in U.S. FDA-regulated industries, 22 as a full-time 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. 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 published 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. John is a graduate of UCLA.
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