Labeling requirements/changes in COVID period

FDA is committed to providing timely guidance to support response efforts to this pandemic situation of COVID-19. In this regard FDA has implemented few guidance documents immediately, the devices submission would be required as per Quality System Regulation requirements (21 CFR Part 820 {21 CFR Subpart K – 820.120 Device labeling & 820.130 Device packaging Control}), Reports of Corrections and Removals requirements (21 CFR Part 806 {reporting information}), and Label to bear a unique device identifier (21 CFR Part 830 and 21 CFR 801.20) regulations as necessary.

The recommended guidance document contains proposed changes in both the device technical function and labeling context (including methods, standards, etc).