Office of Medical Device and Radiological Health Inspectorate (OMDRHI)

Effective February 2, 2026, the FDA will begin implementing the Quality Management System Regulation (QMSR), which replaces the Quality System Regulation (QS reg) within 21 CFR 820 and incorporates ISO 13485:2016 and Clause 3 of ISO 9000:2015 by reference to harmonize FDA’s regulation with those used by other regulatory authorities.

As part of the QMSR implementation, the FDA will discontinue use of the Quality System Inspection Technique (QSIT) for medical device inspections and will instead conduct inspections using the process described in the updated Inspection of Medical Device Manufacturers Compliance Program (CP 7382.850). As of February 2, 2026, the FDA will no longer use Inspection of Medical Device Manufacturers (CP 7382.845) or Medical Device PMA Preapproval and PMA Postmarket Inspections (CP 7383.001).

Quality System Regulation  and Medical Device GMPs

Frequently Asked Questions

What We Do

Inspections

• What should I expect during an inspection?
   
• OII Boundary Map
   
• Divisional & Foreign Inspectional Handouts: 
  • Division West Post-Inspection Handout
  • Division South Post-Inspection Handout
  • Division Northeast Post-Inspection Handout
  • Division Midwest Post-Inspection Handout
  • OMDHRI Foreign Post-Inspection Handout 
  • 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 OIIDEVICES 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 CDRHEnforcement@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. 

  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: CDRHEnforcement@fda.hhs.gov

  For further instructions, refer to our Post-Inspection Handouts 

  • Division West Post-Inspection Handout
  • Division South Post-Inspection Handout
  • Division Northeast Post-Inspection Handout
  • Division Midwest Post-Inspection Handout
  • OMDHRI Foreign Post-Inspection Handout 
  • Mandarin Translation FDA 483 Responses for Foreign Inspections (Jan 2022)

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
• 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

• 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

• QMSR is effective as of February 02, 2026! FDA now conducts inspections using the process described in the updated Inspection of Medical Device Manufacturers Compliance Program (CP 7382.850)
• May 2025: Expanded Unannounced Foreign Inspections
• Federal Register: Public Inspection: Medical Devices: Quality System Regulation
• Correction and Removal Fillable Form for 806 submissions

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 the deputy office director is currently vacant. 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	Vacant

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