Government Affairs

Food and Drug Administration

The Food and Drug Administration’s (FDA) is “ responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.”

AAPM Statements and Comments

• AAPM comments on the draft public health notification
• Public Health Notifications
• FDA Guidance Documents
• Medical Product Safety Alerts

Archives

• FDA MedWatch - Transdermal Drug Patches with Metallic Backings: risk of burns during MRI scans
• Computed Tomography (CT) - Informaiton is provided on the issue of whole body screening using CT.
• Drugs
• Mammography Quality Standards Act (MQSA)
  • FDA Issues new version of MQSA inspection procedures released
• Radiaiton Injuries and Fluoroscopy
• MRI Safety
• Positron Emission Tomography (PET)
• Single-Use Devices
• Clinical Trials Information
• Informational Incidents
  • Drug Preparedness and Response to Bioterrorism
• Information on 510Ks - This link provides information on the 510K process.
  • Recently issued 510Ks
• Recently Approved Devices by the FDA
• Recently Issue Federal Register Notices Applying to FDA