Zdrowie i gospodarka · 21/08/2025
FDA Classifies Postnatal Chromosomal Copy Number Variation Detection System into Class II
The FDA has classified the postnatal chromosomal copy number variation detection system into Class II, a move aimed at ensuring the device's safety and effectiveness while reducing regulatory burdens, thereby enhancing patients' access to innovative devices.
Source: Federal Register — Food and Drug AdministrationOpen original release →