2015 - FDA 510(k) Requirements, Submission, and Clearance: Best Practices

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).
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 Covered in the Session :
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