# Import Alert 89-08: Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)

**Compliance Urgency Score:** 75/100

| Field | Value |
|---|---|
| Alert number | 89-08 |
| Name | Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k) |
| Industry | Medical devices & radiation |
| Type | DWPE |
| Last published | 2026-10-27 |

## Why this score
- Published or updated in the last 30 days.
- Detention without physical examination.

Source: U.S. FDA Import Alerts (accessdata.fda.gov) (https://www.accessdata.fda.gov/cms_ia/importalert_244.html). Last refreshed: 2026-11-03T19:38:30.901Z.
From FDA's published import alert list; the FDA alert page (linked) is authoritative and lists the firms and products covered. Informational only, not regulatory advice.