MedCon 2024, co-sponsored by the FDA

Back to MedCon Agenda 2024

April 24, 2024

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1:50 pm

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2:50 pm

News and Best Practices for Signals Involving Reports of Correction and Removal (806) and Adverse Events (MDRs)

Post Market Track

Are you including the correct and required information when you submit your MDR or 806 Report to the agency? Hear from CDRH and OMDRHO on the new fillable pdf form for 806 Correction and Removal Reports and information that is needed but routinely missing from MDR reports. Speakers will also discuss progress made in integrating UDI information within these reports across the Total Product Lifecycle and assuring it is made publicly available.

Moderator

Susan Matthias, Special Assistant, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA

Speakers

Gina Brackett, Division 1 Director, Compliance Branch, Office of Medical Device and Radiological Health Operations (OMDRHO), Office of Regulatory Affairs (ORA), FDA
Mike Ryan, Deputy Director, Office of Regulatory Programs, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH), FDA