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- FDA updates testing guidance for health emergencies
The FDA has released new guidance that the government says will enhance the availability of diagnostic tests during public health emergencies.
What's new: The updated protocols should expand access to unapproved in vitro diagnostic tests (IVDs), ensuring timely patient care and effective infection control in emergencies.
- It emphasizes assessing public health needs, potential benefits and risks, available alternative IVDs, and mitigations for false results.
- The guidance aligns with Government Accountability Office recommendations and incorporates lessons from COVID-19 and mpox responses.
What's next: The FDA will review and adjust the enforcement policy to remain flexible in addressing evolving public health needs.
- Enforcement actions may still occur for compliance and safety violations, the FDA says.