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

Inspections

• What should I expect during an inspection?
• Divisional & Foreign Inspectional Handouts
  • Inspectional Handout - OMDRHO Division 3 West
  • Inspectional Handout - OMDRHO Division 2 Central
  • Inspectional Handout - OMDRHO Division 1 East
  • Inspection Handout - OMDHRO FDA 483 Responses to 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 ORADEVICES1FMD@fda.hhs.gov
  • Division 2 ORADEVICES2FMD@fda.hhs.gov
  • Division 3 ORADEVICES3FMD@fda.hhs.gov
  • Foreign Branch CDRHforeigninspections@fda.hhs.gov
• Resources used by FDA investigators and inspectors in their daily activities
• FAQS about combination product inspections

Remote Regulatory Assessments (RRA)

• FDA’s remote oversight tools

Recalls

• ORA 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

Compliance

• Exporting Medical Devices

483 Response Information General: 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. Thumb drive or compact disc (cd) may be sent to the address 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.

• Division 1: ORADevices1FirmResponse@fda.hhs.gov
• Division 2: ORADevices2FirmResponse@fda.hhs.gov
• Division 3: ORADevices3FirmResponse@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. 

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 OMDRHO 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

• 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 Regulatory Affairs
• OMDRHO CSO Recruitment Flyer

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