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Donald Miller, MD, FSIR: OPEQ is part of the CDRH. CDRH’s mission is to protect and promote the public health. We ensure that patients and providers have timely and continued access to safe, effective and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent and efficient regulatory pathways, and ensuring consumer confidence in devices marketed in the United States.
IRs in the FDA: How interventional radiologists can get involved in device regulation
By Donald Miller, MD, FSIR, and Minhaj Khaja, MD, MBA, FSIR
responsible for regulating and approving medical devices such as the ones used by interventional radiologists every day.
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This work is accomplished through a combination of in-house staff, advisory committees and FDA’s Network of Experts program (
bit.ly/3Lwp4el), a partnership with professional organizations including SIR.
The society calls on its members to share their expertise with FDA staff by assisting in answering specific questions posed by FDA to help inform CDRH’s
20 IRQ | FALL 2022
he Center for Devices and Radiological Health (CDRH), a branch within the U.S. Food and Drug Administration (FDA), is
regulatory work. From staff positions to advisory committees to expert advice, there are multiple opportunities for IRs to help further the CDRH’s mission.
To better understand these opportunities, Donald Miller, MD, FSIR, chief medical officer of OHT 8: Office of Radiological Health, and Minhaj S. Khaja, MD, MBA, FSIR, a current member of the CDRH Medical Devices Advisory Committee Circulatory System Devices Panel (CSDP) elaborated on the opportunities available to IRs.
Dr. Miller, as CMO of one of the offices within the Office of Product Evaluation and Quality (OPEQ), can you explain its mission?
What are the differences between the OPEQ offices? Which ones are IRs most likely to encounter? DM: OPEQ includes eight Offices of Health Technology (OHTs). They all function similarly, assessing devices during all phases of their development and commercialization—product review, quality, surveillance and enforcement.
The OHTs differ only in the medical devices they regulate.
• OHT 1 deals with ophthalmic, anesthesia, respiratory, ENT and dental devices.
• OHT 2 deals with cardiovascular devices, including essentially all vascular devices used outside the brain.
• OHT 3 deals with gastrorenal, OB-GYN, general hospital and urology devices.
• OHT 4 deals with surgical and infection control devices.
• OHT 5 deals with neurological and physical medicine devices, including interventional neuroradiology devices.
• OHT 6 deals with orthopedic devices. • OHT 7 deals with in vitro diagnostics.
• OHT 8 deals with radiological health, including radiology imaging devices, radiation therapy (including radioactive microspheres) and the Mammography Quality Standards Act (MQSA).
OPEQ also includes an Office of Regulatory Programs (ORP) and an Office of Clinical Evidence and Analysis (OCEA). ORP and OCEA do not deal with specific devices. IRs are most likely to interact with OHT 2, OHT 5 and OHT 8.
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