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Office of Medical Device and Radiological Health Operations (OMDRHO)

On 02/02/2024 the agency published Quality Management System Regulation: Final Rule. Read the rule. For more information read the Frequently Asked Questions FDA.

What We Do

About the Office 

The Office of Medical Device and Radiological Health Operations (OMDRHO) is a program office within the Office of Medical Products and Tobacco Operations (OMPTO), a part the Office of Regulatory Affairs (ORA). 

Anne Reid directs the Office of Medical Devices and Radiological Health Operations. The office structure includes the foreign and domestic medical device and radiological health inspection and operations staff including three divisions with responsibility for oversight of staff conducting inspections, managing compliance activities, recalls, and partnerships. 

Vision

All patients, providers, and consumers are informed, protected, and have access to safe, reliable medical devices and radiological health products

Mission

Protect and enhance public health by minimizing risk and by supporting access to safe, effective and quality medical devices and radiological health products.

Quality Policy

OMDRHO will consistently provide products and services that meet or exceed the requirements and expectations of our customers. We will actively pursue improving quality through programs that enable each employee to do their job right the first time and every time.

Key Contacts 

Position Name Email
Program Director Anne Reid  Anne.Reid@fda.hhs.gov
Deputy Program Director Rhonda Mecl Rhonda.Mecl@fda.hhs.gov

Program Division Directors (PDD) 

Position Name Email
Division 1 Program Division Director  Joseph Matrisciano Joseph.Matrisciano@fda.hhs.gov
Division 2 Program Division Director Blake Bevill Blake.Bevill@fda.hhs.gov
Division 3 Program Division Director Shari Shambaugh Shari.Shambaugh@fda.hhs.gov
Director of Foreign Operations Akbar Zaidi Akbar.Zaidi@fda.hhs.gov
Operations and Mammography Staff Director Vacant  

 

 



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