FDA 510(k) Requirements, Submission, and Clearance: Best Practices

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Description:

This presentation will walk you through how to prepare and submit 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).

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July 28, 2014, FDA issued the finalized 510(k) guidance integrating a total of 400 comments received in response to the Draft Guidance issued on December 28, 2011.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.

From this webinar, you will

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 and much more

Areas to be Covered:

Applicable statute(s), regulations, and definitions
Device classification
Who is subject to a 510(k)
FDA guidance for 510(k) program
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

Who will Benefit:

Medical Device Quality and Compliance Professionals
Pharmaceutical Compliance Professionals
Quality
Regulatory Affairs
CEOs
VPs
Attorneys
Clinical Affairs
Research & Development
Consultants
Contractors/Subcontractors
Anyone Interested in the 510(k) Matters

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). 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 and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

This product is currently out of stock and unavailable.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance