What We Do
- What should I expect during an inspection?
- FAQS about combination product inspections
- Divisional & Foreign Inspectional Handouts
- Resources used by FDA investigators and inspectors in their daily activities
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: email@example.com
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.
- 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
- A Day in the Life - Medical Device Program
- Our Work Our Voice - Hear OMDRHO employees describe their roles at FDA
- Consumer Complaints - How to Report Problems
- Import Program Resources
- Consumer Updates - Health Fraud
About the Office
- 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).
Jan Welch 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.
All patients, providers, and consumers are informed, protected, and have access to safe, reliable medical devices and radiological health products
Protect and enhance public health by minimizing risk and by supporting access to safe, effective and quality medical devices and radiological health products.
|Program Director||Jan Welch||Jan.Welch@fda.hhs.gov|
|Deputy Program Director||Anne Reid||Anne.Reid@fda.hhs.gov|
Program Division Directors (PDD)
|Division 1 & Division Director (DD)||Joseph Matrisciano||Joseph.Matrisciano@fda.hhs.gov|
|Division 2||Blake Bevill||Blake.Bevill@fda.hhs.gov|
|Division 3||Shari Shambaugh||Shari.Shambaugh@fda.hhs.gov|
|Director of Foreign Operations||Akbar Zaidi||Akbar.Zaidi@fda.hhs.gov|
|Operations and Mammography Staff Director||Rhonda Mecl||Rhonda.Mecl@fda.hhs.gov|