FDA Import Alert 99-34 and Detention Without Physical Examination

1. Key takeaways

Under FDA Import Alert 99-34, the current edition of which was amended on October 18, 2023, products from firms without valid drug or medical device registration and/or listing may be subject to Detention Without Physical Examination (DWPE), meaning the shipment can be detained without any physical inspection. The route to release is to provide evidence that the firm is registered with FDA and that the device has been listed as required. For foreign manufacturers, this import alert is the enforcement mechanism that turns a lapsed registration or listing into detained cargo at the United States border.

• Trigger: products from firms without valid registration and/or listing, per Import Alert 99-34.
• Consequence: Detention Without Physical Examination, with no physical inspection required to hold the shipment.
• Release: evidence that the firm is FDA-registered and the device is listed as required.
• Current edition amended 2023-10-18; source accessdata.fda.gov.
• Underlying obligations: registration under FD&C Act Section 510(i)(1) and listing under Section 510(j).

2. Legal basis

Import Alert 99-34 sits at the end of a legal chain that runs from the statutory registration and listing obligations, through the misbranding consequences of failing them, to detention at the port of entry. Each link is identified below.

3. Expert insights

Insight 1: The trigger is an ‘or’ condition, not an ‘and’ condition.

According to the name and stated rationale of Import Alert 99-34, the trigger is a firm ‘without a valid drug or medical device registration and/or listing’. So long as either element is missing, detention can be triggered. This formulation forecloses the comfort of believing that a partially completed registration offers any protection: a firm that is registered but has not listed its device, or that has listed a device under an establishment whose registration has lapsed, falls within the alert’s scope either way. Compliance must therefore be binary on both tracks at the same time, valid registration and valid listing together, before a shipment is offered for entry.

Insight 2: The legal chain runs from obligation to misbranding to detention.

FD&C Act Section 510(i)(1) and Section 510(j) establish the registration and listing obligations. Section 502(o) characterizes a device that is not listed as misbranded. FDASIA, signed on 2012-07-09, further clarifies that products of unregistered foreign establishments are misbranded. Import Alert 99-34 is the enforcement instrument that applies this chain at the clearance stage. Reading the chain in order explains the logic of the alert: the detention is not an arbitrary border measure but the operational consequence of statutory obligations whose breach the statute itself already defines as misbranding.

Insight 3: The path to release is providing evidence, not automatic release once the paperwork is fixed.

Under Import Alert 99-34, to seek the release of detained goods, the owner or consignee should provide evidence that the firm is registered with FDA and that the device has been listed as required. This means the sequence is fixed: first complete the registration and listing, then submit the evidence, then await release. A company cannot expect that a rushed registration filing made after detention will release the shipment automatically or immediately. The detained period should be planned for as a real waiting period, and the evidence package should be assembled in advance so that the release request is not delayed by missing documentation.

Insight 4: The alert and the 21 CFR 807.22(c) status lapse are mutually causal.

A missed registration or listing deadline places the establishment in the failed to register or failed to list status under 21 CFR 807.22(c). At clearance, an establishment in that status is treated as a firm without valid registration and/or listing, which brings the shipment within Import Alert 99-34 and leads to detention. This is the complete path that connects deadline management to border risk: the calendar obligations discussed elsewhere in this guide are, in enforcement terms, the first line of defense against detained shipments, and the import alert is what happens when that line fails.

4. Practical recommendations

The measures below make registration and listing status a shipping gate rather than a paperwork archive.

• Treat valid registration plus valid listing as a mandatory pre-release check item before any shipment.
• Before shipping, verify on the FDA website that the establishment’s status is active, and retain a screenshot of the verification.
• Keep the product codes used in listing consistent with those used at customs declaration, to avoid mismatch questions.
• If detained, follow the sequence of completing registration and listing first, then providing evidence, then waiting for release; do not expect immediate release from a rushed filing.
• Include the registration and listing status of contract manufacturers within the scope of verification.

5. Verification checklist

Confirm each item below before releasing a shipment for entry into the United States.

• □ The establishment’s registration status has been verified as active before shipment.
• □ The device’s listing has been verified as valid before shipment.
• □ The product codes used at customs match the listing records.
• □ The registration and listing status of contract manufacturers has been verified.
• □ Evidence of the registration and listing status has been retained.
• □ An evidence package for detention scenarios has been assembled, covering the registration number, listing number, and payment receipts.

Regulatory information verified as of October 28, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, US Agent and local testing support for the United States market. Our team manages FDA establishment registration and listing, 510(k)/De Novo/PMA submissions, and supports post-market reporting obligations. Business enquiries: info@grzanglobal.com