Business · 17/12/1997Updated: 10/17/2026 · 1 min read
FDA Announces Availability of Guidance for Tumor-Associated Antigen Medical Devices
The FDA is making available a guidance document outlining the requirements for submitting premarket notifications for tumor-associated antigen medical devices, including suggestions for nonclinical and clinical studies to ensure safety and effectiveness.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →