HPA, FDA & MassMEDIC present webinar to discuss 510(k) quality and the Revised FDA Refuse to Accept Guidance document

Join us for a webinar on Sep 25, 2015 at 12:00 PM EDT.

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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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