Preparing a 510(k) Premarket Notification

The regulation and control of new or substantially changed medical devices for sale in the US is primarily  based on the 510(k) (along with PMA or DeNovo submissions). 510(k)s now can only be submitted to the FDA under the eSTAR  (electronic Submission Template And Resource) Portal.  What are the key steps and supporting documentation required.

This webinar will discuss current US Federal law  on the 510(k),  and associated requirements for getting a new or substantially changed medical device through the US FDA review process and to market in the USA.  US law and the FDA require that a device be the subject of an approved marketing application and review but the US FDA  before it is transported or distributed across state lines foes le in the US. Since October 1, 2023, the 510(k) submission is to be only by electronic means under the FDA's new eSTAR submission portal, with it's specific submission templates. Although the means of submission has changed, the basic content and purpose of the 510(k) has not.  It's purpose is still to prove safety and effectiveness by means of a documented and tested comparison between the new / changed device, and an identified predicate device.   

Why You Should Attend:

For decades, the regulation and control of new or substantially changed class II, medium risk, medical devices for sale in the United States (no matter where manufactured has been based on a paper and e-copy  510(k) submission and FDA review process.  That has all changedd as of October 2023.  Now a 510(k) clearance for Class II devices  required prior to commercialization, can only be submitted for review through the Agency's new eSTAR portal. However the basic submission content hasn't really changed.  Also, the 510(k) process has had some recent modification to allow for newer technology (Breakthrough) or increased safety (STeP).  And new Cybersecurity, Machine Learning and Artificial Intelligence features add additional complexity to the process.  

Areas Covered in the Session :

• The new eSTAR Device Submissions and the US FDA
• The 510(k) process
• The Major Sections of a 510(k)
• Documentation Requirements to Meet 510(k) Requirements
• Cybersecurity Submission Requirements
• New 510(k) Mod programs, Breakthrough and STeP, and Q-Sub
• Machine Learning and Artificial Intelligence Issues - FDA "Principles"
• Post-market requirements

Who Should Attend:

• Senior management in Devices, Combination Products
• Quality Assurance Departments
• Regulatory Affairs Departments
• Research and Development Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Production Departments
• Medical Device product development teams
• Consultants; others tasked with device product development, manufacturing, process / product / data analysis,  regulatory submission responsibilities

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.