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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​