Online Webinar 2019 - Live Webinar US FDA 510(k): Best Practices for 510(k) Preparation and Submission

Session Highlights
Statute(s) and Regulations
Definitions
Guidelines for 510(k) Requirements
Selecting a Predicate Device
510(k) and De Novo Process
How To Demonstrate Substantial Equivalence
510(k) Contents And Format
Addressing Technical and Regulatory Requirements.
510(k) Submission Quality
Responding to FDA’s Request Of Additional Information
How to Resolve Different Opinions and What Process to Take
Avoiding Common Mistakes with Awareness
510(k) Trends
Best Practices for 510(k) Preparation and Submission: Dos and Don’ts
Speaker’s PASS-IT Recommendations
This Webinar is intended to provide practical and actionable guidelines on premarket notification [510(k)] preparation and submission to the US Food and Drug Administration (FDA).
The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements. 510(k) is the most common pathway to bring medical devices including in vitro diagnostic medical devices (IVDs) into the US market.
To obtain a clearance, the 510(k) is first submitted to the US FDA, demonstrating that the subject device (to be marketed) is substantially equivalent to a legally marketed device(s) (predicate device) as described in 21 CFR 807.92(a)(3). In other words, firms must demonstrate that a proposed product is substantially equivalent to another, a legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA). Over time, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process.
Who will benefit
Regulatory associates, specialists, managers, directors and VPs
Clinical associates, specialists, coordinators, managers and directors
Quality associates, specialists, engineers, managers, and directors
R&D associates, scientists, managers, and directors
Site managers, and consultants
Other stakeholders interested in 510(k) preparation and submission
Faculty
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor . As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author