FDA Device Inspections: What FDA Entry Point Handles as U.S. Agent

How FDA Entry Point handles a device inspection

FDA Entry Point receives CDRH correspondence through the foreign establishment’s designated U.S. Agent record, relays it to the manufacturer, and coordinates inspection scheduling, pre-inspection readiness, Form 483 response work, and regulatory follow-up. The service includes QMSR documentation review support, post-inspection corrective action planning, 24/7 emergency availability, and escalation of recalls, Medical Device Reports, and safety alerts. FDA Entry Point medical-device U.S. Agent services.

Under 21 CFR 807.40(b)(2), a device U.S. Agent assists FDA with communications, questions about imported devices, and inspection scheduling. If FDA cannot contact the foreign establishment directly or expeditiously, documents delivered to FDA Entry Point can be treated as delivered to the establishment. FDA medical-device U.S. Agent requirements.

FDA Entry Point runs the FDA-facing side of the inspection and works alongside the manufacturer’s quality function. The manufacturer retains ownership of its quality management system, technical explanations, root-cause analysis, corrective actions, records, and evidence of implementation.

The Quality Management System Regulation became effective on February 2, 2026. On that date, FDA stopped using the Quality System Inspection Technique and began inspecting under Compliance Program 7382.850, so inspections conducted from February 2, 2026 onward use the QMSR framework. FDA QMSR requirements and inspection process.

Responsibility map from inspection notice to close-out

Inspection sequence based on the 2026 FDA Investigations Operations Manual, Compliance Program 7382.850, and FDA Entry Point’s published inspection-support scope.
Stage	What FDA does	What the manufacturer owns	What FDA Entry Point handles
Standing record readiness	Reviews establishment registration, device listings, marketing authorizations, MDR information, and required GUDID records during pre-inspection preparation.	Maintains accurate facility identity, establishment activities, device data, marketing status, and quality-system records.	Supports FURLS/DRLM registration, device listing, DUNS maintenance, GUDID/UDI submissions, annual renewal tracking, and U.S. Agent confirmation.
Inspection notice and scheduling	Preannounces qualifying medical-device inspections. Foreign establishments generally receive more than five calendar days’ notice, although FDA retains authority to conduct unannounced for-cause inspections.	Confirms facility availability, responsible personnel, site access, and the ability to produce requested records.	Receives and escalates the notice, coordinates scheduling and logistics, and keeps the CDRH communication path active across time zones.
Pre-inspection readiness	Can identify the inspection’s nature, expected duration, number of FDA personnel, and some records expected to be requested.	Assembles the applicable QMSR procedures, records, subject-matter experts, device files, complaint information, and postmarket evidence.	Provides readiness guidance, supports QMSR documentation review, organizes the request list, and checks the inspection package against registration, listing, and GUDID records.
Inspection execution	Inspects under 21 CFR Part 820 and Compliance Program 7382.850, including applicable QMSR, MDR, corrections and removals, UDI, registration, and listing requirements.	Provides facility access, technical explanations, controlled records, process evidence, and personnel who can explain the quality system.	Coordinates FDA-facing communications, routes additional requests, and maintains a controlled record of questions, commitments, and requested follow-up.
Close-out meeting	Discusses inspection findings with management and issues Form FDA 483 when observed conditions could constitute violations. Registration and listing discrepancies are also discussed at close-out.	Clarifies facts, identifies completed corrections, assigns technical owners, and decides whether to annotate individual observations.	Captures each observation and commitment, records FDA’s response instructions, and opens the corrective-action response workstream.
Form 483 response	Considers written corrective actions, plans, and supporting evidence received within 15 business days after the inspection closes when deciding whether further action is appropriate.	Performs root-cause analysis, defines technical corrections and preventive actions, approves commitments, and produces implementation evidence.	Builds the observation-by-observation response matrix, coordinates corrective-action planning, checks that evidence matches each commitment, and manages FDA correspondence and submission routing.
EIR and inspection classification	Completes the Establishment Inspection Report and evaluates the Form 483, collected evidence, and manufacturer response before assigning NAI, VAI, or OAI status.	Continues corrective actions and preserves evidence demonstrating that each action was completed and remains effective.	Routes the classification and follow-up requests, tracks open commitments, and coordinates further written responses or FDA meetings.
Warning Letter, import action, or close-out	Can issue a Warning Letter, conduct a follow-up inspection, or recommend detention without physical examination under an applicable Import Alert. A Warning Letter close-out letter requires completed corrective actions that FDA has evaluated and verified.	Completes and sustains corrections, supplies supporting records, and addresses the technical conditions that produced the enforcement action.	Escalates the communication, manages the FDA-facing response calendar, organizes evidence, and coordinates follow-up through regulatory close-out.

Registration records that an inspection can expose

Compliance Program 7382.850 instructs investigators to discuss registration and listing discrepancies with management during the inspection close-out and record any commitments to correct them. Inspection readiness therefore includes both the quality system and the regulatory records that identify the establishment and its devices.

Record requirements and system mechanics are drawn from FDA’s registration and listing schedule, DRLM U.S. Agent confirmation instructions, and current medical-device inspection program.
Record	FDA rule or inspection check	FDA Entry Point handling
Establishment registration	Registration must be submitted annually through FURLS/DRLM between October 1 and December 31, even when no information has changed.	Coordinates the annual registration workflow, checks the establishment record, and tracks completion of the renewal.
Device listing	Device listings must be reviewed during the same October 1 to December 31 annual cycle and updated when devices, activities, or manufacturing relationships change.	Supports listing creation and updates and checks that listed devices match the establishment’s current U.S. activities.
GUDID and UDI data	FDA’s pre-inspection process includes searching AccessGUDID to confirm that required device information has been submitted.	Supports GUDID/UDI submissions and aligns the device data used for inspection preparation with current product records.
DUNS and facility identity	DRLM records include the facility name, address, DUNS number, establishment type, and associated devices. Inconsistent identity data can create a registration discrepancy.	Supports DUNS maintenance and checks the facility identity used across the establishment record and related filings.
U.S. Agent confirmation	The designated agent has 10 business days to confirm the emailed DRLM receipt code. A non-response cancels the code, removes the agent information, and requires the establishment to designate an agent that has agreed to serve.	Accepts the designation, maintains the U.S. Agent record, and keeps contact information available for FDA communications and inspection scheduling.

Changes to facilities, devices, addresses, ownership, or agent details should be reflected in the appropriate FDA record rather than deferred to the annual cycle. The operational triggers are documented in Medical Device Change Triggers for FURLS, U.S. Agent and GUDID Updates.

Illustrative 15-business-day Form 483 response calendar

This calendar assumes FDA issues Form FDA 483 at an inspection close-out meeting on Monday, March 2, 2026. The 15-business-day period begins on Tuesday, March 3 and ends on Monday, March 23, with no federal holiday falling inside the period.

The 15-business-day response mechanics follow FDA’s medical-device inspection program and Form FDA 483 procedures.
Point in the sequence	Manufacturer action	FDA Entry Point action
Before the inspection	Prepares personnel, QMSR records, device files, complaint and MDR information, and current registration data.	Coordinates the FDA notice, schedule, readiness work, and document-request structure.
March 2, close-out	Receives and discusses each Form 483 observation, identifies factual clarifications, and assigns a technical owner.	Records each observation, annotation, FDA instruction, contact, and commitment in the response matrix.
March 3 to March 23	Completes root-cause analysis, defines corrective actions, supplies supporting records, and approves the final response.	Coordinates corrective-action planning, checks that every observation has a direct answer and supporting evidence, and manages FDA-facing correspondence.
March 23, business day 15	Authorizes the completed response and its stated commitments.	Coordinates delivery to the FDA contact identified at close-out and preserves the submitted response record.
After FDA receives the response	Implements unfinished actions and maintains evidence showing that completed corrections remain effective.	Tracks requests, classification communications, Warning Letter correspondence, follow-up inspection activity, and regulatory close-out.

A Form 483 is not FDA’s final determination. FDA evaluates it together with the Establishment Inspection Report, collected evidence, and the manufacturer’s response before deciding whether the inspection is NAI, VAI, or OAI and whether a Warning Letter, follow-up inspection, or import action is appropriate. FDA inspection classifications.

Urgent MDR, recall, and safety communications

FDA Entry Point maintains 24/7 emergency availability for device recalls, MDR-related communications, and safety alerts. It receives or escalates the FDA contact, brings the manufacturer’s regulatory and quality owners into the response, and coordinates the communication path with CDRH. FDA Entry Point emergency-contact scope.

The U.S. Agent designation does not transfer the manufacturer’s technical or statutory responsibility for Medical Device Reporting, corrections and removals, or quality-system decisions. FDA Entry Point supports the FDA-facing response; the manufacturer determines reportability, supplies product and event facts, authorizes regulatory submissions, and executes any field action.

Urgent event	FDA Entry Point handling	Manufacturer ownership
MDR inquiry or adverse-event escalation	Routes the inquiry, coordinates the response team, and supports communication with FDA.	Evaluates reportability and owns the content, accuracy, and filing of required MDR information.
Recall, correction, or removal	Escalates FDA communications and coordinates the regulatory response track.	Makes the technical field-action decision, controls affected-product data, and performs required reporting and execution.
Safety alert or urgent CDRH request	Maintains the emergency contact path and organizes the manufacturer’s response and supporting records.	Provides the risk assessment, device history, affected populations, technical explanation, and corrective measures.

Frequently asked questions

Does FDA Entry Point provide QMSR inspection support beyond forwarding FDA mail?

Yes. FDA Entry Point coordinates CDRH inspection scheduling and logistics, provides pre-inspection readiness guidance and QMSR documentation review support, organizes Form 483 response work, supports post-inspection corrective action planning, and escalates urgent recalls, MDR-related contacts, and safety alerts. The manufacturer’s quality function remains responsible for the technical quality-system content and implementation evidence.

What happens after FDA issues a Form 483 during a device inspection?

The manufacturer should submit its written response, corrective actions, plans, and supporting evidence within 15 business days after the inspection closes. FDA reviews the Form 483 together with the Establishment Inspection Report, inspection evidence, and the response before assigning an inspection classification or deciding whether to issue a Warning Letter or pursue another action. FDA Compliance Program 7382.850.

Can FDA treat documents sent to FDA Entry Point as delivered to the foreign manufacturer?

Yes. When FDA cannot contact the foreign establishment directly or expeditiously, 21 CFR 807.40 allows FDA to provide information or documents to the designated U.S. Agent, and that delivery is treated as equivalent to delivery to the foreign establishment. FDA Entry Point therefore routes official CDRH communications through the manufacturer’s named regulatory and quality contacts.

Who owns CAPA and the technical response to inspection observations?

FDA Entry Point coordinates the FDA-facing response and corrective-action workstream, while the manufacturer owns root-cause analysis, technical CAPA content, implementation, effectiveness evidence, and management approval. This split keeps communication, deadlines, and response structure controlled without separating quality-system decisions from the people responsible for the device and its manufacturing processes.

What happens if the U.S. Agent does not confirm the DRLM designation?

FDA cancels the receipt code and removes the unconfirmed U.S. Agent information after 10 business days. CDRH then informs the foreign establishment and requests an amended registration naming an individual or organization that has agreed to serve. FDA Entry Point completes the confirmation step as part of maintaining the active agent relationship. FDA DRLM confirmation instructions.

Are foreign medical-device inspections always announced in advance?

No. FDA’s 2026 inspection manual identifies foreign medical-device inspections as appropriate for preannouncement and states that foreign preannouncement is generally more than five calendar days because of country-clearance requirements. FDA retains authority to conduct unannounced for-cause inspections, so the U.S. Agent communication path and the manufacturer’s inspection records must remain current outside a scheduled inspection window. FDA Investigations Operations Manual, Chapter 5.