ASTROgram: ASTRO comments to FDA on device safety

On July 15, ASTRO filed comments with the Food and Drug Administration (FDA) advocating for enhanced collaboration among users, independent evaluators and vendors to improve device safety and effectiveness. The letter emphasized the need for a national medical event reporting system for radiotherapy administrations and recommended enhanced training and quality management. The comment letter follows the FDA public meeting in June, titled "Device Improvements to Reduce the Number of Under-Doses, Over-Doses, and Misaligned Exposures from Therapeutic Radiation." ASTRO will continue its collaboration with the FDA, industry, professional organizations and others to identify issues impacting radiotherapy safety and to assist the FDA in crafting viable solutions. For more information, contact ASTRO's senior legislative and regulatory analyst, Richard Martin.