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Market Surveillance & Import Alerts

US-unique

FDA's import alert system and Detention Without Physical Examination (DWPE) are US-specific enforcement mechanisms for controlling the entry of non-compliant devices at the US border.

Import alerts​

An import alert is a notice from FDA to US Customs and Border Protection (CBP) that devices from a specific manufacturer, shipper, or country may be subject to refusal of admission into the USA. Import alerts may be based on:

  • QMSR violations identified during inspections
  • Adulterated or misbranded device findings
  • Failure to have required 510(k) clearance or PMA approval
  • Unregistered establishment

Detention Without Physical Examination (DWPE)​

When an import alert is in effect, FDA may detain a shipment at the US border without physically inspecting it — based solely on the existence of the import alert.

Detained shipments may be:

  • Refused entry (returned to the sender or destroyed)
  • Released if the importer provides adequate documentation demonstrating compliance

Getting off an import alert​

To be removed from an import alert, the manufacturer typically must:

  1. Identify and correct the root cause of the violations
  2. Provide FDA with evidence of adequate corrections
  3. Undergo a follow-up FDA inspection (domestic or foreign)
  4. Demonstrate sustained compliance

Official resources​

Import alerts​

FDA typically notifies the manufacturer via the established US Agent contact when an import alert is placed. The notice includes the reason for the alert and the violations that triggered it. Importers and CBP agents are also informed of the alert through FDA's system.