A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (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) as described in 21 CFR 807.92(a)(3)
For the past few years, the 510(k) program has been evolving (e.g., 510(k) actions and improvements)
This webinar will discuss:
How to identify and assess the regulatory requirements
How to meet the regulatory requirements
How to increase 510(k) submission quality
How to format a 510(k) submission to proactively facilitate the review process
Some template forms, which are applicable for both general medical devices and in vitro diagnostic devices, will be discussed.
Why Should you Attend:
If you don’t know the answers to the following questions, you should attend this webinar.
What is 510(k)? What is a 510(k) submission?
What are the applicable federal statutes and implementing regulations for 510(k) submissions?
How the medical devices are classified?
What are the challenges and hurdles during the 510(k) preparation, submission, and review process?
How to identify applicable regulatory requirements?
How to address applicable regulatory requirements (e.g., performance requirements including clinical studies, if applicable)?
What are the common deficiencies in 510(k) submissions?
How to format a 510(k) submission using the CAC-SI method?
Objectives of the Presentation:
FDA regulations applicable to a 510(k) submission
List of applicable FDA guidance documents
List of applicable reference standards
Systematic methods to increase 510(k) submission quality.
Formatting a 510(k) for submission
Live Session for one participant
Corporate Live Session 4 to 10 participants in single location.
Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.
For more information