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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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Office of Medical Device and Radiological Health Inspectorate (OMDRHI)

The U.S. Food and Drug Administration (FDA) has reorganized effective October 1, 2024, to a new model for its field operations and other significant modernization efforts. Please see the May 30, 2024 announcement for further information: FDA’s Reorganization Approved for Establishing Unified Human Foods Program, New Model for Field Operations and Other Modernization Efforts.
 
Specifically, the FDA is changing the name of Office of Regulatory Affairs (ORA) to the Office of Inspections and Investigations (OII) to better convey the organization’s role as the frontline of the FDA, which provides real time insights and science‐based evidence necessary to ensure the safety and quality of products Americans depend on. 
 
This webpage has been updated for OMDRHI and includes information to help you understand our new organization.
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

Useful Links

About the Office 

The Office of Medical Device and Radiological Health Inspectorate (OMDRHI) is a program office within the Office of Medical Products and Tobacco Operations (OMPTO), a part of Office of Inspections and Investigations (OII). OMDRHI protects and promotes public health by conducting oversight, through inspections and investigations primarily of medical devices, radiological health products, and performs inspectional oversight of Mammography facilities. OMDRHI coordinates, directs, and conducts domestic and foreign inspections and investigations. OMDRHI manages medical device and radiological health recalls within our new Risk Mitigation and Response branch within our Division of Global Operations.

OMDRHI also provides direction and guidance to OII leadership and agency leaders relative to these areas that are regulated by Center for Devices and Radiological Health (CDRH). The office provides direction and counsel relative to medical device, mammography and radiological health field operations, in collaboration with CDRH, including response activities posed by potential threat to public health. In collaboration with CDRH, OMDRHI establishes inspection goals and annual workplan. OMDRHI supports the development of policy, develops guidance for inspections, and provides evidence to support compliance activities for medical device and radiological health firms and products. 

Anne Reid directs the Office of Medical Devices and Radiological Health Inspectorate, and Rhonda Mecl is the deputy office director. OMDRHI has 6 divisions, including 4 domestic Division of Medical Device and Radiological Health Inspectorates (West, South, Northeast, and Midwest); Division of Medical Device and Radiological Health Global Operations (Operations Branch, Foreign Operations Branch, and Risk Mitigation and Response Branch); and Division of Mammography and Radiological Health Inspectorate (Mammography Operations Branch 1 and Mammography Operations Branch 2).  

While we may have changed our name and a few elements of our structure, our Vision, Mission and dedication to our Quality Policy have not changed.

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

OMDRHI 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
Office Director Anne Reid  Anne.Reid@fda.hhs.gov
Deputy Office Director Rhonda Mecl Rhonda.Mecl@fda.hhs.gov

Program Division Directors (PDD) 

Position Name Email
Northeast Division Director  Joseph Matrisciano Joseph.Matrisciano@fda.hhs.gov
South Division Director Blake Bevill Blake.Bevill@fda.hhs.gov
West Division Director Shari Shambaugh Shari.Shambaugh@fda.hhs.gov
Midwest Division Director Vacant  
Global Operations Division Director  Vacant  
Foreign Operations Branch Chief  Akbar Zaidi Akbar.Zaidi@fda.hhs.gov
Mammography and Radiological Health Division Director Vacant  

 

 



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