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 In this section:

        ORA Program Areas

Office of Medical Device and Radiological Health Operations (OMDRHO)

                        
                A Day in the Life - Medical Device Program
          Frequently Asked Questions About FDA Inspections of Combination Products
          OMDRHO 2022 Annual Virtual Conference - 07/13/2022
          OMDRHO Events & Conferences
          UGA/FDA 9th Annual Medical Device Regulations Conference - 11/15/2022 Home
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          ORA Program Areas
          Office of Medical Device and Radiological Health Operations (OMDRHO)ORA Program Areas Office of Medical Device and Radiological Health Operations (OMDRHO)
  	
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Inspections
	What should I expect during an inspection?
	FAQS about combination product inspections
	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)
	Resources used by FDA investigators and inspectors in their daily activities

Remote Regulatory Assessments (RRA)
	FDA’s remote oversight tools

Recalls
	ORA Recall Coordinators
	Recalls, Corrections and Removals (Devices)
	OMDRHO Device Correction Removal Report Model for Industry (Rev 04)
	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.govPlease 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
	Quality System (QS) Regulation/Medical Device Good Manufacturing Practices
	Proposed Rule: Quality System Regulation Amendments – Frequently Asked Questions
	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

Medical Device Recalls and Reports of Corrections and Removals, Part 7, Part 806: Frequently Asked Questions
	Federal Register :: Public Inspection: Medical Devices: Quality System Regulation
	Philips Respironics Recall FAQ
	Office of Medical Devices and Radiological Health Operations Divisions Boundary Map
	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
			EmailProgram Director
			Anne Reid
			Anne.Reid@fda.hhs.govDeputy Program Director
			Rhonda Mecl
			Rhonda.Mecl@fda.hhs.gov**Program Division Directors (PDD)**

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

                                                                                  Content current as of:
      08/01/2023
                  
                   
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsOffice of Medical Device and Radiological Health Operations (OMDRHO)                
                          

                        A Day in the Life - Medical Device Program
          Frequently Asked Questions About FDA Inspections of Combination Products
          OMDRHO 2022 Annual Virtual Conference - 07/13/2022
          OMDRHO Events & Conferences
          UGA/FDA 9th Annual Medical Device Regulations Conference - 11/15/2022
 
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