Zdrowie i gospodarka · 05/11/2010
FDA Reclassifies Full-Field Digital Mammography System from Class III to Class II
The US Food and Drug Administration (FDA) has reclassified the full-field digital mammography system from a Class III device requiring premarket approval to a Class II device with special controls, allowing for a more streamlined regulatory process.
Source: Federal Register — Health and Human ServicesOpen original release →