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

Inspections

• What should I expect during an inspection?
   
• New OII Boundary Map
   
• Communication Resources following an inspection: 
  • OMDRHI Division 1 West 
  • OMDRHI Division 2 South
  • OMDRHI Division 3 Northeast
  • OMDRHI Division 4 Midwest
  • OMDHRI Foreign Inspections
  • Mandarin Translation FDA 483 Responses for Foreign Inspections (Jan 2022)
     
• After an inspection – Obtaining the report
  Field Management Directive 145 provides criteria and instructions for releasing one copy of an Establishment Inspection Report (EIR), to the firm’s top management official or designee at the inspected firm.  EIRs will be transmitted via electronic means, when conditions in the FMD are met, from an ORADEVICES email (see below, per division) The EIR will come secured with a password issued in a separate email. If you have issues or concerns with your EIR, please reach out to the appropriate email address for resolution.
  • Division 1 West OII-DEVICES-West-FMD145@fda.hhs.gov
  • Division 2 South OII-DEVICES-South-FMD145@fda.hhs.gov 
  • Division 3 Northeast OII-Devices-Northeast-FMD145@fda.hhs.gov 
  • Division 4 Midwest OII-Devices-Midwest-FMD145@fda.hhs.gov 
  • Foreign Branch CDRHforeigninspections@fda.hhs.gov
     
• Resources used by FDA investigators and inspectors in their daily activities
   
• 483 Response Information
  How do I submit my FDA-483 Response following my inspection?
  E-mail your inspection-related correspondence to the email address listed below. Please include your company’s FEI number, if known, in the subject of the email, and on the cover letter or documentation. Hard copy responses are discouraged, but if that is the only way you can send a response, please use the address listed below. 
  
  We prefer e-mail correspondence due to efficiency, fiscal responsibility, expedited service to stakeholders and environmental awareness. The Division will acknowledge receipt of your e-mail (size limit 100 megabytes) to the email box for your firm's geographic location.
  • Domestic:
    • Division 1 West OII-DEVICES-West-Firm-Response@fda.hhs.gov 
    • Division 2 South  OII-DEVICES-South-Firm-Response@fda.hhs.gov 
    • Division 3 Northeast OII-DEVICES-Northeast-Firm-Response@fda.hhs.gov 
    • Division 4 Midwest OII-DEVICES-Midwest-Firm-Response@fda.hhs.gov
  • Foreign: cdrhforeigninspsections@fda.hhs.gov
  
  Please be sure that any attachments are readily labeled and/or identified for ease of review to include the FEI number. Documentation should be submitted as a single pdf file, with bookmarks to easily identify table of contents, memos, attachments, etc. If a single pdf file exceeds the 100MB size limit, please submit multiple pdf files, with bookmarks, as appropriate. Please do not provide multiple folders that contain individual files as this will delay the processing of your response. There is no need to provide a back-up hard copy of any correspondence sent via email or provided in thumb drive or cd format. 

Recalls

• OII OMDRHI Recall Coordinators
• Recalls, Corrections and Removals (Devices)
• Correction and Removal Fillable Form For 806 submissions
• Medical Device Recalls and Reports of Corrections and Removals, Part 7, Part 806: Frequently Asked Questions

Remote Regulatory Assessments (RRA)

• FDA’s remote oversight tools

Useful Links

Exporting Medical Devices

• Exporting Medical Devices

Medical Device Databases

• 510(k) Premarket Notification Database
• Device Registration and Listing Database
• Product Code Classification Database
• MAUDE (Manufacturer and User Facility Device Experience) Database
• Premarket Approvals (PMA) Database
• All Medical Device Databases

CDRH Related Links

• Final Rule: Quality Management System Regulation: Final Rule Amending the Quality System Regulation
• Quality Management System Regulation: Final Rule Amending the Quality System Regulation – Frequently Asked Questions
• Overview of Device Regulation
• Quality System Regulation/Medical Device Good Manufacturing Practices
• Device Advice: Comprehensive Regulatory Assistance
• Division of Industry and Consumer Education (DICE)
• CDRH Learn
• Unique Device Identification System (UDI System)
• MDSAP - Medical Device Single Audit Program
• MQSA - Mammography Quality Standards Act and Program

Additional Information

• A Day in the Life - Medical Device Program
• Our Work Our Voice - Hear OMDRHI employees describe their roles at FDA 
  • LCDR Matthew Morrison, MQSA Specialist
  • Theresa Kirkham, Recall Coordinator
  • Brittani Franklin, Foreign Cadre 
  • Sean Moynihan, Compliance Officer
  • Adaliz Santaliz-Cruz, Medical Device Specialist 
• Consumer Complaints - How to Report Problems 
• Import Program Resources
• Consumer Updates - Health Fraud

About the Office 

Hot Topics

• New OII Boundary Map
• Federal Register: Public Inspection: Medical Devices: Quality System Regulation
• New! Correction and Removal Fillable Form for 806 submissions
• Work with Us - Visit Jobs at the Office of Inspections and Investigations 
• OMDRHI CSO Recruitment Flyer

The Office of Medical Device and Radiological Health Inspectorate (OMDRHI) is an office within the Medical Products Inspectorate (MPI) under the 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.

Click to view full size image (with states listed) PDF

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