Food and Drug Administration (FDA)

The Food and Drug Administration is charged with the promotion and protection of the public health by helping safe and effective products reach the market in a timely manner. It also oversees the labeling of the products it approves and monitors these products for continued safety after they are brought to market.

ACR works to foster the efficiency of the FDA approval process to ensure that patients have prompt access to the newest technology available. We provide comments to the FDA as their regulatory policies evolve through a formal rulemaking process. ACR staff and physician representatives also liaison with agency staff and serve as a resource to them where doing so will benefit the patients we serve.

FDA Guidance - Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use
US FDA-CDRH Class I Recall Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System
Information for Healthcare Professionals: Micro-bubble Contrast Agents (marketed as Definity and Optison)
FDA Removes Several Contraindications from Labeling of Ultrasound Contrast Agents
FDA Preliminary Public Health Notification Regarding Possible Medical Device Malfunctions
FDA Revises Process for Responding to Drug Applications
FDA Proposes Reclassification of Full Field Digital Mammography from Class III to Class II
FDA Proposes Guidance for Dissemination of Information on Unapproved Uses of Medical Products

FDA Names Permanent Director for Center for Drug Evaluation and Research
FDA Guidance for Industry and Staff: Expedited Review of Premarket Submissions for Devices
FDA Ultrasound Contrast Warning
510(k)s Final Decisions Rendered for August 2007
Recent Approved Products
FDA Public Advisories-Safety Alerts
TEPRSSC

Useful Links

Food and Drug Administration (FDA)