FDA announces transition plan for medical devices

The FDA this week announced a transition plan for medical devices that fall with the emergency use authorization enforcement policies issued during the Covid-19 pandemic.

Guidances that set forth Covid-19-related enforcement policies for certain devices initially stated that they were intended to remain in effect for the duration of the pandemic declaration. The declaration is now anticipated to expire at the end of the day on May 11, 2023.

In an announcement on March 13, the FDA revised the guidance documents to state that it would continue to be in effect for 180 days after the declaration expires unless a different intended duration is set forth in the finalized version of the guidance.

The enforcement policies relating to the following devices used during the Covid-19 public health emergency:

• Remote digital pathology devices
• Imaging systems
• Non-invasive fetal and maternal monitoring devices used to support patient monitoring
• Telethermographic systems
• Digital health devices
• Extracorporeal membrane oxygenation and cardiopulmonary bypass devices
• Remote ophthalmic assessment and monitoring devices
• Infusion pumps and accessories
• Face shields, surgical masks and respirators
• Gowns, other apparel and gloves, – Sterilizers, disinfectant devices and air purifiers
• Ventilators and accessories and other respiratory devices
• Modifications to FDA-cleared molecular influenza and RSV tests
• Coagulation systems for measurement of viscoelastic properties
• Viral transport media

The FDA’s new guidance is intended to help facilitate continued patient, consumer and healthcare provider access to devices needed to prevent, treat and diagnose Covid-19. The agency believes that the policies and recommendations in the new guidance will help ensure an orderly and transparent transition for devices that fall within the guidance.

The transition timeline will be a phased approach.

• Phase 1: Begins on the implementation date. Manufacturers will follow 21 CFR Part 803 in order to prepare for phase 3.
• Phase 2: Begins 90 days after the implementation date. Before the start of Phase 2 and in order to prepare for Phase 3, manufacturers should follow 21 CFR Part 806, and if planning to continue to distribute their devices after phase 2, should also follow 21 CFR Part 807 Subparts B-D.
• Phase 3: Begins 180 days after the implementation date. After the 180-day transition period ends, the guidance in the list will no longer be in effect. The FDA does not intend to object to the continued distribution of devices within the scope of this guidance where a required marketing submission has been submitted and accepted by the FDA before the start of Phase 3.

Medical Design & Outsourcing