FDA Unveils 3-Phase Approach For Bringing Products Back Under Compliance After Pandemic Enforcement Leeway

The US FDA says in a new draft guidance document that makers of a variety of devices and diagnostics that were given wide enforcement berth by the agency to use their products to respond to COVID-19 must eventually transition back to full regulatory compliance under a proposed three-phase plan.

Hand is turning a cube and changes the word 'Phase 2' to 'Phase 3'.
• Source: Alamy

Makers of a variety of devices and diagnostics that were given enforcement leeway by the US Food and Drug Administration to use their products to respond to COVID-19 must eventually transition back to full regulatory compliance under a three-phase transition plan recommended by the agency in a new draft guidance document.

Published in the Federal Register on 23 December, the 24-page “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency” is a companion doc to another draft guidance released by the agency on 22 December. That separate draft explains how manufacturers of emergency use authorized (EUA) devices can transition those products to full marketing clearance or approval. (See

More from Compliance

More from Policy & Regulation

What’s A Diagnostic? WHO Wants To Know

 
• By 

The World Health Organization is seeking input from stakeholders to create an official definition of the term ‘diagnostics.’ This initiative follows a 2023 resolution aimed at enhancing global diagnostics capacity; the definition, it is hoped, will help drive the creation of effective health policies. Comments will be accepted until 23 May.

‘Help Us Deregulate’: RFK Announces RFI For Trimming Government Health Agencies

 

HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.