U.S. FDA’s 510(k), IDE, and PMA Documentation, Submission and Approval Process

What are the various routes to US FDA device clearance / approval? 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. What is the De Novo provision? The US classification system. For clinical trials, an IDE (Investigational Device Exemption) submission is required. 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 required 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? The 3 types of 510(k)s and when used. The 21 mandatory elements will be addressed. Tougher requirements, Changed requirements, Software “in-” or “as-product”? How does Product Risk Management fit into the submission process? will also be discussed.

Areas Covered in the Session : 

• The different US FDA product submission requirements and their uses
• The 510(k) — Pre-market ‘notification’ and FDA Device Clearance
• Predicates and Substantial Equivalence
• The IDE, IRBs, required disclosures
• The De Novo alternative
• The PMA
• The 21 “must have” requirements of the 510(k)
• Three types of 510(k)s
• Software / firmware documentation requirements
• Pre-submission meetings – when advisable
• The e-copy

Who Should Attend:

• Senior Management
• Middle Management
• QA Departments
• RA Departments
• R&D Departments
• Operations Departments
• Production Departments
• Manufacturing Departments
• Engineering Departments
• Marketing Departments
• Medical Device Consultants

Course Director: JOHN E. LINCOLN

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 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 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 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. He writes a recurring column for the Journal of Validation Technology. John is a graduate of UCLA.