Case-specific support for medical-device shipments detained by FDA or subject to Detention Without Physical Examination (DWPE) — including notice review, corrective-action strategy, entry evidence, compliance remediation, and Import Alert removal requests.
FDA may detain an imported medical device when the product appears to violate the FD&C Act or applicable FDA requirements. If FDA places a product, firm, or other responsible party on an Import Alert, future entries may be subject to Detention Without Physical Examination (DWPE). FDA's import authority is based on section 801 of the FD&C Act; 21 CFR Part 807 may be relevant when registration or listing is part of the violation, but it is not the legal basis for every Import Alert or detention.
The correct response depends on the case. A detained entry may require testimony or evidence to address that shipment, while removal from DWPE requires evidence that the conditions leading to the Import Alert have been resolved and that future shipments are expected to comply. FDA evaluates the totality of evidence and the applicable Import Alert's Guidance section.
Support tailored to the detained entry, applicable Import Alert, underlying violation, and evidence FDA needs to evaluate the case.
We review the Notice of FDA Action, applicable Import Alert, entry details, establishment and device information, and FDA correspondence to identify the apparent violation and the available response pathway.
We help investigate the root cause and organize case-specific corrective and preventive actions addressing registration, listing, QMSR, labeling, UDI/GUDID, premarket status, inspection issues, or other applicable device requirements.
We prepare and organize supporting records, explanations, audit or testing evidence, shipment history, compliance corrections, and other documentation appropriate for an individual entry response or Import Alert removal request.
We help coordinate follow-up with the appropriate FDA contact identified in the Notice or Import Alert Guidance and support continuing registration, listing, quality, labeling, and import-compliance maintenance after the immediate case is addressed.
Helping companies organize the facts, correct the underlying compliance issue, and present case-specific evidence to FDA.
FDA compliance support provided to companies across regulated industries.
International and U.S. companies supported with FDA regulatory matters.
Established regulatory-support history for companies entering and operating in the U.S. market.
Investigation, corrective actions, preventive measures, and case-specific supporting evidence.
A four-step process that separates the detained-entry response from any broader DWPE removal strategy.
We review the Notice of FDA Action, Import Alert Guidance when applicable, entry information, device details, and FDA correspondence to identify the apparent violation and deadlines.
We help define the investigation, root cause, corrective actions, preventive measures, and regulatory corrections appropriate to the problem identified by FDA.
We organize testimony, records, audit or laboratory evidence, registration or listing corrections, shipment information, and other documentation needed for the detained entry or removal request.
The response or removal request is directed to the appropriate FDA contact identified by the Notice or Import Alert Guidance, followed by case-specific communication as FDA reviews the evidence.
Related services that may be relevant when the detention or Import Alert involves registration, listing, labeling, quality systems, U.S. Agent information, or another medical-device compliance issue.
FDA establishment registration support for applicable domestic and foreign medical-device facilities.
Device listing support with product-code and classification review for applicable devices.
Review labels, packaging, IFU, UDI/GUDID considerations, and applicable FDA device-labeling requirements.
DUNS request and verification support for FDA medical-device registration and related CDRH workflows.
Annual U.S. Agent representation for applicable foreign medical-device establishments and FDA communications.
Professional verification documentation prepared from applicable FDA registration and listing records; not FDA-issued.
QMSR gap assessments, ISO 13485 alignment, CAPA, documentation, and FDA inspection-readiness support.
Annual registration review, user-fee coordination, listing review, and renewal support.
Case-specific support for detained entries, DWPE, corrective actions, evidence packages, and Import Alert removal requests.
Prepare the FDA Laser Product Report / Radiation Safety Product Report, coordinate CDRH submission, and follow the accession number for applicable laser products.
Current answers covering DWPE, detained entries, response deadlines, evidence, removal requests, medical-device violations, and FDA follow-up.
An FDA Import Alert is an enforcement tool FDA uses to identify products, firms, or other responsible parties that may be subject to detention without physical examination (DWPE). FDA uses the appearance standard in section 801 of the FD&C Act, and each Import Alert's Guidance section explains how the alert is applied and what may be needed for individual shipment release or removal from DWPE.
DWPE means FDA may detain an imported product without first physically examining or testing that specific shipment when the product, firm, or responsible party is subject to an applicable Import Alert. The importer or consignee may still have an opportunity to submit testimony or evidence under the alert's Guidance section.
No. FDA specifically states that not all import detentions are caused by Import Alerts. The Notice of Detention and Hearing, issued through a Notice of FDA Action, identifies the apparent violation and the response deadline for that particular entry.
They are separate issues. For an individual detained shipment, the importer or consignee may submit evidence showing the entry does not have the violation identified by FDA. Removal from DWPE requires a broader showing that the conditions that led to the Import Alert have been resolved and that future shipments are expected to be compliant.
FDA considers the totality of the evidence. Depending on the Import Alert and violation, a removal request may include investigation findings, root-cause analysis, corrective actions, preventive measures, updated compliance records, audit evidence, shipment history, testing, or other documentation identified in the alert's Guidance section.
No. FDA gives clean shipments as one possible type of evidence, but there is no universal five-shipment rule for every Import Alert. Some specific alerts may call for five or another number of non-violative commercial shipments, while other alerts rely on different evidence. The applicable alert's Guidance section controls.
FDA issues a Notice of Detention and Hearing that provides the apparent charges and a respond-by date. The responsible party can submit testimony or evidence to overcome the appearance of the violation, request an extension when appropriate, or pursue an authorized method of bringing the product into compliance if FDA permits it.
FDA's current detention guidance states that its Regulatory Procedures Manual allows 10 business days from the date of detention to provide testimony. To account for weekends, holidays, and mailing time, the Notice of FDA Action often specifies a longer calendar period. The deadline printed on the actual notice should be treated as controlling for the entry.
If FDA does not receive a response by the applicable respond-by date, the compliance officer may issue a refusal of admission. A refused shipment generally must be exported or destroyed under FDA and CBP supervision within the applicable timeframe.
Medical-device detentions and Import Alerts can involve different issues, including quality-system deficiencies, missing required premarket authorization, refusal of a foreign inspection, invalid establishment registration or device listing, UDI or GUDID problems, labeling issues, or other apparent violations. The specific charge and applicable Import Alert must be reviewed case by case.
Not in a single standardized format. FDA requires evidence appropriate to the violation showing that the conditions leading to DWPE have been resolved and that future shipments are expected to comply. A documented corrective-action package is often useful, but the required evidence depends on the alert, product, and facts of the case.
FDA does not identify a general user fee simply for submitting an Import Alert removal request. A case can still involve other costs, such as laboratory testing, audits, registration or listing fees, inspection-related expenses, or professional services, depending on what is needed to resolve the underlying violation.
Only when registration or listing is part of the underlying problem or otherwise required for the establishment and device. FDA's current medical-device import process verifies registration and listing when applicable, but Import Alerts may arise from many different violations. The corrective strategy should match the actual charge.
Yes. We can review the Notice of FDA Action and supporting records, help identify the apparent violation, organize testimony or an evidence package for the detained entry, and separately evaluate whether an Import Alert removal request or broader corrective action is needed.
A foreign medical-device establishment that is required to register with FDA must designate one U.S. Agent as part of its establishment registration. The U.S. Agent requirement is separate from the evidence needed to release a detained entry or remove a firm or product from DWPE, although current registration information should be addressed when it is relevant to the case.
Send us the Notice of FDA Action, Import Alert number if one applies, entry or shipment details, device and establishment information, and any prior FDA correspondence. We will review the case, identify the applicable response or removal pathway, and provide a custom scope and quote.
Send the Notice of FDA Action, Import Alert number if applicable, establishment and device information, and any FDA correspondence so we can review the case and confirm the appropriate scope.
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