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Recorded Webinar
What you need to know about the FDA 510(k) Process
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
FDA requires a 510(k) premarket notification submission for most Class II medical devices, some Class I devices, and even for a few Class III devices – it’s by far the most common type of medical device premarket submission. This webcast presents an overview of 510(k) submissions – when to submit, what kind of 510(k) to use and when, contents of each 510(k) type, the 510(k) review process, and pitfalls to avoid with your submission.
The presentation will cover the following areas:
- History of 510(k) regulations.
- When to file a 510(k).
- Who must file a 510(k).
- Predicate devices and substantial equivalence.
- Types of 510(k) submissions.
- Contents of a 510(k).
- 510(k) Review process.
- Pitfalls and common mistakes
- Resources for more information
Who should attend
Anyone who is interested in learning more on FDA Medical Device Regulations
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