Successful 510(k) Submissions

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

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 37 years’ experience in U.S. FDA-regulated industries, 23 as an independent consultant. John has worked with companies from start-up to Fortune 100, worldwide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, submissions, process / product / equipment including QMS and software validations, ISO 14971 product risk management and human factors files / reports, Design History Files, Technical documentation. He's held positions in Engineering, QA, QAE, RA, 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, written numerous chapters for books on validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.

Topic Background:

A US FDA Task Force 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. Current methods are claimed to not be providing the product safety or efficacy seemingly promised. What can companies do proactively to address these concerns and better ensure a smoother review process. Growing high-profile field problems indicate that change control and it’s effect on regulatory review activities are not yet fully utilizing the power of current risk management tools, which must be a part of s 510(k) submission. What can companies do in proactively addressing these issues, to "put the reviewer's mind at ease" when reviewing a 510(k)? Fully complying with the 21 key requirements can be met by implementation of formal methods with documented, and defensible rationale.

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