- Date: to be scheduled upon request
- Time: TBD
- Duration: 60 Minutes.
About the Seminar
This presentation will walk you through how to best prepare and submit a traditional premarket notification [510(k)] to the 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. On July 28, 2014, FDA issued the finalized 510(k) guidance integrating a total of 400 comments received in response to the Draft Guidance issued on December 28, 2011. 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, 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 in your 510(k) submission for successful clearance.
About the Benefits to Attend
- Gain and receive great guidance on 510(k) preparation, submission and clearance
- Get the latest information
- 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
About the Areas to Be Discussed
- Applicable statute(s), regulations, and definitions
- Device classification
- Who is subject to a 510(k)
- FDA guidance for 510(k) program, issued on July 28, 2014
- What actions require a 510(k) including three types of 510(k)s
- How to identify a predicate(s), if any.
- 510(k) program (Refuse to Accept Policy) – Compiled RTA Items Cited by FDA
- e-Copy Program
- Product type-specific 510(k) contents-recently cleared
- What to include and address in 510(k) submissions.
- 510(k) contents and format
- How to present scientific, technical, and/or clinical data.
- How to demonstrate substantial equivalence (SE).
- How to increase 510(k) submission quality.
- How to respond to FDA’s request of additional information.
- How to resolve different opinions between the submitter and FDA reviewer(s), if any.
- PASS-IT suggestions/recommendations
About the Intended Attendee(s)
- Professionals from Regulatory Affairs, R&D, Clinical Affairs, Quality
- Anyone interested in FDA 510(k) submissions.
About the Seminar Speaker
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 including 510(k)s in various forums and meetings. Recently, Dr. Lim developed 510(k) templates (ensuring to address the applicable requirements) 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. Dr. Lim serves as a member of the Advisory Board for Inspection Insider published by FDAnews.
We will contact you upon your payment below to schedule LIVE 510(k) seminar (online) at your convenient time.
- Option 1: you may send your “request to purchase” by email to Global Compliance Seminar
- Option 2: you may request an invoice by email to Global Compliance Seminar
- Option 3: you may purchase below using a credit card or PayPal below.
LIVE (≤ 5 attendees): $599
LIVE (≥ 6 attendees): $999
LIVE & Recorded: $299