In September 2025, the FDA issued its guidance “Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency.”
What’s new?
- The guidance lays out factors the FDA will consider when deciding whether to issue enforcement policies for manufacturers offering unapproved in vitro diagnostic (IVD) tests during a declared emergency under Section 564 of the FD&C Act.
- It clarifies how flexibility can be applied, balanced against patient safety, performance data, and public health urgency.
- It does not provide blanket waivers
- The guidance is intended to be forward-looking: to help stakeholders understand how the FDA may respond in future emergency situations involving diagnostic needs.
Why it matters for diagnostics and regulated quality environments?
- Regulatory flexibility under pressure – During emergencies, rapid diagnostic solutions may be needed; this guidance defines how regulators may ease enforcement, while retaining oversight.
- Risk / benefit balance – Requires demonstration that the potential public health benefit outweighs risks from limited validation or incomplete data.
- Sustaining trust & compliance – Even under relaxed enforcement, manufacturers must maintain robust traceability, justification, and post-market surveillance.
If you want to explore how this FDA guidance applies to your diagnostics business or IVD development, Instituto Pedro Nunes is here to help.
Read more here.