Join us for a webinar on Sep 25, 2015 at 12:00 PM EDT.
Register now!
https://attendee.gotowebinar.com/register/7100566196753420290
Background
Presenters:
Juan Carlos Serna, Vice President &
Brian Young Vice President, Regulatory & Quality
Health Policy Associates, Inc.
- Discussion of how FDA has historically reviewed 510(k)’s for completeness.
- FDA’s rationale for introducing detailed RTA checklists and the relationship to MDUFA III performance goals.
- Analysis of submission refusal rates after introduction of the 2012 RTA Policy and checklist
- Issues with the original 2012 RTA checklist and its implementation
The New Refuse to Accept Guidance
Presenter:
Marjorie Shulman, Chief of Premarket Notification (510(k), Center for Devices and Radiological Health, FDA
Michael Bailey, Biologist, Premarket Notification 510(k), Center for Device and Radiological Health, FDA
- Summary of changes to the RTA policy and checklists
- How FDA is preparing internally and training its reviewers in the new guidance
- Recommendations for high quality submissions and first pass acceptance
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About HPA
Health Policy Associates has spent more than 20 years providing high quality consulting services to the medical device and biotech community, helping companies bring their innovations to market. As specialists in regulatory compliance and clinical consulting, HPA helps medical and biotech manufacturers optimize their product development processes while avoiding potential pitfalls. From clinical trial strategy and design to precision data analysis, HPA’s team of industry experts has guided leading manufacturers around the globe to regulatory success again and again, with unrivaled accuracy and efficiency.
For more information on HPA, click here.
