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Questions and Answers About the FDA Radiological Health Program

Q: What is FDA's role in protecting the public from radiation?
Q: How will the 2005-2010 Plan for the Radiological Health Program enhance public health?
Q: What are the key elements of the 2005-2010 Plan for the Radiological Health Program?
Q: How will industry learn about the 2005-2010 Plan for the FDA Radiological Health Program?


Q: What is FDA's role in protecting the public from radiation?
A: FDA oversees radiation safety of medical imaging systems, counter-terrorism security systems (such as baggage and passenger screening systems for airline security), and industrial and electronic consumer products that emit radiation (such as microwave ovens, lasers, and tanning booths). For these products, FDA establishes performance standards, recommends good practices, and conducts educational activities to encourage safe use.

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Q: How will the 2005-2010 Plan for the Radiological Health Program enhance public health?
A: FDA is changing the focus of its Radiological Health program to adapt to current public health needs. The new focus takes into account worldwide performance standards, global markets for new products, and significant changes in the technologies of radiation-emitting products. The program will focus resources on the products and procedures with the highest risks to the public, including those that affect the greatest number of people or cause the most severe problems.

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Q: What are the key elements of the 2005-2010 Plan for the Radiological Health Program?
A: The key elements of the program are to:

  • collect and publish national exposure data for different procedures to help facilities manage patient radiation exposures. FDA will also encourage all medical x-ray facilities to routinely assess their exposures and compare them to the national data.
  • review and revise product reporting requirements to reduce unnecessary burden on manufacturers.
  • harmonize U.S. requirements with international standards to remove conflicting requirements on manufacturers while maintaining appropriate levels of protection.
  • maintain FDA scientific and technical expertise in radiation instrumentation and measurement.
  • continue research on ways to reduce radiation risks and population exposures.
  • establish a coordinated education program on how to use electronic products appropriately and minimize unnecessary exposures.

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Q: How will industry learn about the 2005-2010 Plan for the FDA Radiological Health Program?
A: FDA will post web pages, notify trade and professional groups, and communicate with industry on an ongoing basis.

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Updated October 10, 2005

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