Radiation-Emitting Products
Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of CDRH, on FDA’s updates to Medical Device Safety Action Plan to Enhance Post-Market Safety
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Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on FDA’s updates to Medical Device Safety Action Plan to enhance post-market safety Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health - Outlines how FDA will encourage innovation to improve safety.
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Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health Pediatric X-ray Imaging This page explains the different types of medical imaging procedures that are used on children. -
Pediatric X-ray Imaging Radiological Health Program - File radiation safety product reports electronically.
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Radiological Health Program
Navigate the Radiation-Emitting Products Section
Introduction to all radiation-emitting products and procedures.
Radiation SafetyThis page contains information about the FDA’s Center for Devices and Radiological Health (CDRH) radiation safety programs.
Mammography Quality Standards Act and ProgramWelcome to the FDA's Mammography Program within the Center for Devices and Radiological Health. This website informs mammography facility personnel, inspectors, and other interested individuals about the implementation of the Mammography Quality...
This page contains information about CDRH's Electronic Product Radiation Control Program
News and Events (Radiation-Emitting Products)This page contains links to News and Events related to radiation-emitting Products.
Resources for You (Radiation-Emitting Products)Resources relating to the FDA Radiological Health Program.
FDA Radiological Health ProgramThe mission of the FDA’s radiological health program is to protect the public from hazardous or unnecessary radiation exposure from radiation-emitting electronic products.
Industry Assistance Walkthrough
Industry Favorite Links
Device Advice: Comprehensive Regulatory Assistance CDRH Learn Medical Device Webinars and Stakeholder Calls Getting a Radiation Emitting Product to Market - Radiation-Emitting Products Guidance Documents
- Acknowledgement Letters and Accession Numbers
Addresses for Electronic Product Radiation Control Reports and Recordkeeping Importing and Exporting Electronic Products Radiation-Emitting Product Codes Search X-Ray Assembler Database Search - Laws and Regulations
Performance Standards: Radiological Health Program - Recent Scientific Publications
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Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56) - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 118KB)The FDA Recommends Against Using Laserworld and Ray Technologies International Laser Projectors: FDA Safety Communication Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57) - Draft Guidance for Industry and Food and Drug Administration Staff (PDF - 465KB)Laser Pointer Safety Video 
CDRH Strategic Priorities and Updates
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Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue WO66-4613
Silver Spring, MD 20993