Mark N. Melkerson

Mark N. Melkerson

Panelist

Deputy Director, OHT6-Orthopedic Devices, Office of Product Evaluation and Quality,

FDA

Mr. Melkerson is Deputy Director, OHT6-Orthopedic Devices, Office of Product Evaluation and Quality, Center for Devices and Radiological Health (CDRH) at FDA. He joined FDA in 1987 and has served in director and leadership roles since 1990.

Mr. Melkerson previously served in roles as Director for the Division of Surgical, Orthopedic and Restorative Devices, Director of the Division of Orthopedic Devices and acted as Director of the Division of Surgical Devices during the selection process for the newly created division. In the most recent Total Product Life Cycle reorganization, which combined the Office of Device Evaluation, the Office of Compliance and the Office of Surveillance and Biometrics, Mr. Melkerson was selected as the Deputy Office Director of the Office of Health Technology 6 (OHT6) – Orthopedic Devices. In addition, Mr. Melkerson is a CDRH representative to FDA’s Tissue Policy Team and Tissue Reference Group. He serves as CDRH’s primary liaison to ISO/TC 150 and ASTM Committee F04 standards. He is co-chair of the cross-center Tissue Engineering/Regenerative Medicine Steering Committee and a member of the CDRH Management Council.

My Session

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June 15,2021

Global Regulatory Roundtable: FDA and Notified Bodies Outlook

3:00 pm-4:30 pm

Room 45