AAPM Government Affairs - Food and Drug Administration (FDA)

Federal Agencies

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.”

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.

AAPM comments on the draft public health notification

Posted 7-08

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

AAPM Statements and Comments

Public Health Notifications

FDA Guidance Documents

Medical Product Safety Alerts

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