Regulatory Update


FDA to Revamp Radiation Health Program

Amid a diminishing budget and changing public health needs, the Food and Drug Administration's Center for Devices and Radiological Health (CDRH) is redesigning how it manages its radiation protection responsibilities. At a recent unveiling of the center's plans for change, John McCrohan, CDRH's deputy director, Office of Communication, Education, and Radiation Programs, outlined the center's intentions in the areas of standards, monitoring, education, research, and program management.

Standards

  • Increased use and reliance on international consensus standards
  • Establishment of processes to ensure conformance with appropriate international standards, as well as mandatory standards when international standards are not available or appropriate
  • Use of performance standards that are enforceable, appropriate for current equipment, and that do not inhibit technological advances
  • Increased FDA and stakeholder participation in development of international and national consensus standards (focusing on dose-intensive equipment)
  • Conformance to consensus standards by agency guidance documents, followed by adopting standards by reference (CT, ultrasound, and other diagnostic x-ray)
  • Pursuing legislative changes to allow for adoption and enforcement of voluntary consensus standards
  • Enforcement actions based on risk assessment

Monitoring

  • Maintain awareness of radiation-emitting electronic products and manufacturers
  • Assess electronic product emissions and conditions of use
  • Understand effects of emissions and exposure risk
  • Require only essential manufacturer reporting
  • Move from routine field and lab test measurements in favor of for-cause testing
    • Eliminate measurement of dose during MQSA inspections
    • Phase out routine laboratory and field test measurement capabilities
    • Phase out instrument calibration functions in favor of maintaining instrumentation expertise and measurement capabilities
  • Emphasize assessment of use and exposures by harvesting data rather than direct measurement

Education

Goals:

  • A public that is able to make informed choices about their own exposure to radiation-emitting products in the medical, occupational, and home setting
  • Users of radiation-emitting products able to minimize their own exposures and those of people they expose
  • Manufacturers of radiation-emitting products who are able to understand their responsibilities and are sensitive to radiation risk issues
  • FDA and state radiation control programs that actively encourage users to assess exposure and minimize radiation risk

Activities:

  • Create a coordinated education program, partnering throughout the radiological health community to disseminate information and create training opportunities
  • Invest in the World Wide Web as an educational tool

Research

  • Increased influence of the radiological health program on the selection of center research
    • Engage radiological health program managers
    • Develop a process to assess and validate ongoing radiological health-related research activities

The ACR will fully engage with the FDA as they adapt their radiological health activities to the new political and sociopolitical realities. Please watch for additional updates on the ACR Web site at www.acr.org.

NIH Reauthorization

The House Energy and Commerce (E&C) Committee';s Subcommittee on Health has begun holding hearings on pending reauthorization of the National Institutes of Health. Reauthorization is the legislative process for updating and restructuring discretionary government programs.

House E&C Committee Chair Joe Barton (R, Tex) anticipates the introduction of a bipartisan reauthorization bill this summer. Among Barton's restructuring priorities for NIH:

  • Expanding the NIH director's authority to transfer funds between institutes and expand trans-NIH initiatives
  • Better aligning NIH's budget lines
  • Creating a more transparent reporting system to ensure the appropriate tracking of research progress in key areas

The ACR will continue to monitor the reauthorization process and work to ensure appropriate funding levels for research in areas that will benefit members' patients and practices.