|When:||« Back to Calendar March 2, 2017 @ 8:30 am - 10:00 am|
21 Drydock Ave #410w
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Presented by Michael Drues, Ph.D., President, Vascular Sciences
For medtech companies working to bring their devices to market, ineffective communication with FDA often leads to time-consuming and costly delays. For example, the manufacturer assumes a classification or regulatory pathway for a new device that has not yet been established-only to learn later that FDA disagrees. One way to mitigate such problems is to take advantage of the FDA’s Pre-Submission Program.
The ‘pre-sub’ program-an expansion of the pre-IDE program now collectively referred to as ‘Q-Sub’- allows manufacturers to request meetings regarding development and testing of devices currently under development and/or under regulatory review. Although CDRH issued guidance on the pre-sub program in February 2014, many companies do not use this program effectively, and some don’t use it at all for fear their regulatory burden will be increased rather than reduced.
When used effectively, pre-subs can offer significant advantages to the manufacturer, such as getting their device to market sooner. But if not managed properly, pre-subs can add tremendous burden to the manufacturer by increasing the time to market. Knowing when not to use the pre-sub process is just as important as knowing when to use it.
This seminar will use the case study approach, to present the pre-sub process in an interactive fashion including: