Webinar · Palm Beach, Florida
Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process
Education, Training
Key numbers
- Editions on record
- 3first in 2011
About Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process
This 3 hour Webinar is a primer and overview to the premarket notification process, i.e., a 510(k). A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA
Objectives:
Know the differences between the Traditional, Special and Abbreviated submissions
Understand Substantial Equivalence and how it is applied
Who is required to submit the application to FDA
Where to submit the 510(k) and what to expect with the review and approval process
When it is and is not required if you are a device company
Exemptions to the submission process and special considerations
How to locate a "predicate" device and go through the content and format of the 510(k)
Understand the De Novo process and the expectations for possibly marketing a low risk device
Understand the potential impact of FDA's proposed changes to the 510(k) process and why manufacturers need to pay attention
Compliance4All
Adam Fleaming
Phone: +1-800-447-9407
Event Link:http://bit.ly/1KjeMGm
support@compliance4all.com
www.compliance4all.com
From our listing of this edition. Details may have changed since.
Editions
| Year | Dates | Where | Exhibitors | Visitors |
|---|---|---|---|---|
| 2015 | 10 Mar 2015 | Webinar Venue Online | — | — |
| 2012 | 16 Aug 2012 | Online | — | — |
| 2011 | 17 Nov 2011 | Webinar Venue Online | — | — |
Past editions from the bvents archive (2008–2019) and organiser figures where they were published.
Questions
When is Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process?
The next dates haven't been confirmed. The last edition we have on record was 10 Mar 2015.
Where is it held?
The last edition we have was at Webinar Venue, Palm Beach, Florida.
How often does it take place?
Irregular, judging by the 3 editions on record since 2011.