White Papers

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).

Labeling requirements/changes in COVID period

Key Elements to Look Out For:

Below are some of the medical devices types as per new recommendations.

  • Remote Ophthalmic Assessment and Monitoring Devices
  • Sterilizers, Disinfectant Devices, and Air Purifiers
  • Infusion Pumps and Accessories
  • Face Masks and Respirators
  • EUAs for Face Masks and Respirators

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