This presentation will walk you through how to prepare and submit a pre-submission package as well as a traditional premarket notification [510(k)] for successful clearance from US FDA. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).
The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the 510(k) requirements. The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device). In other words, a 510(k) must demonstrate that a proposed product is substantially equivalent to another, legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA).
Over the years, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process. To expedite the process of bringing a product to market through the 510(k) program, it is imperative the medical device makers understand the recent changes including pre-submission (Q-submission), prepare and submit a quality 510(k) in a way to expedite the review process for fast and successful clearance.
In this 60-min presentation, the speaker will guide you through the details of the required elements ("Best Practices: Dos and Don’ts") in your Q-submission as well as 510(k) submission for successful clearance. You will have opportunities to bring great value and benefit to your firm’s pre-submission, 510(k) preparation and submission for successful clearance in an efficient and effective manner.
About the Benefits to Attend
- Gain and receive great guidance on 510(k) preparation, submission and clearance
- Get updated with the latest information and tips
- Learn the critical areas and common mistakes
- Improve your current practice
- Recognize what is important
- Become better aware of and get familiar with the 510(k) process
- Much more.
- Statute(s) And Regulations
- Device Classification And Predicates
- 510(k) Program
- When 510(k)s Are Required
- Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.
- Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format
- Substantial Equivalence: Factors to Consider and Special Considerations
- Addressing e-Copy And RTA Policy Requirements
- Applicable Standards and Guidance
- 510(k) Contents And Format
- Common Pitfalls and How to Prevent Them
- What to Ensure While Preparing Your Q-Submission and a 510(k) Application
- Responding to FDA’s Request of Additional Information.
- Resolving Different Opinions and Interpretations
- Best Practices for a Q-submission
- Best Practices for a 510(k) Preparation, Submission and Clearance
- Speaker’s PASS-IT Suggestions: Best Practices
Dr David Lim,
President and Principal Consultant ,
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. 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 seven 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 and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.