FDA Medical Device Registration & Compliance Services

FDA medical device establishment registration is the annual registration of establishments that perform activities covered by 21 CFR Part 807. Registration identifies the establishment and its activities in FDA's registration and listing system and is reviewed annually between October 1 and December 31.

Foreign establishments engaged in covered device manufacturing or processing activities for devices imported into the United States must identify one U.S. Agent as part of establishment registration. The U.S. Agent serves as a communications liaison with FDA and must confirm the designation electronically.

Most establishments that are required to register are also required to list the devices they manufacture or process and the activities performed on those devices. U.S. initial importers are a notable exception: they register and identify the foreign manufacturers and devices they import rather than creating device listings as manufacturers do.

FDA generally classifies devices as Class I, II, or III based on risk and the level of regulatory controls needed. Many Class I devices are exempt from premarket notification, many Class II devices require 510(k) clearance unless exempt, and many Class III devices require Premarket Approval (PMA), subject to device-specific requirements.

FDA's Device Registration and Listing Module includes a DUNS number field as part of facility information, and FDA uses Dun & Bradstreet information in facility verification activities. If your establishment does not yet have or cannot verify its DUNS information, FDA Registration Assistance can help resolve that before filing.

An FDA Import Alert provides field personnel with information about products or firms that may be subject to detention without physical examination (DWPE). The effect depends on the specific Import Alert, firm, product, and entry circumstances; resolving an alert generally requires addressing the underlying compliance issue and presenting appropriate evidence to FDA.

PMA is the FDA's most stringent review process, required for most Class III devices. It requires valid scientific evidence — typically clinical data — demonstrating that the device is safe and effective.

FDA's Quality Management System Regulation (QMSR), effective February 2, 2026, is the current device CGMP framework in 21 CFR Part 820. It incorporates ISO 13485:2016 by reference and includes additional FDA-specific requirements. Applicability depends on the establishment and device, including any applicable exemptions.

Establishment registration information must be submitted each year between October 1 and December 31. Listing information is reviewed during the same annual period, and updates should also be made when relevant changes occur.

If required annual registration is not kept current, the establishment may no longer appear as currently registered for the new registration year. This can create import and compliance problems, including FDA entry review issues, until registration and applicable fee requirements are resolved.

Yes. Establishments may complete registration and listing directly through FDA's FURLS/Device Registration and Listing Module. Professional assistance can be useful when determining establishment activities, product codes, listing relationships, U.S. Agent information, or applicable premarket references.

Our service typically prepares and submits complete registration or listing work within 24–48 hours after receiving the required information and any applicable FDA payment confirmation. FDA processing, payment posting, registration-number assignment, and database updates can take additional time and are outside our control.

Many Class I devices are exempt from 510(k) premarket notification, but the establishments that manufacture or process them may still be required to register and list under 21 CFR Part 807. Applicable QMSR, labeling, MDR, UDI, and other requirements depend on the device and establishment activity.

Medical Device Reporting under 21 CFR Part 803 requires manufacturers, importers, and device user facilities to submit certain adverse-event reports. The events and reporting obligations differ by reporter type; manufacturers also have malfunction-reporting obligations when the regulatory criteria are met.

Yes. We can review medical device labeling and Instructions for Use against applicable FDA labeling requirements, including 21 CFR Part 801 and UDI requirements where applicable. The exact labeling obligations depend on the device, intended use, distribution status, and any device-specific regulation.

Documentation depends on your role and device. Common records include establishment registration and listing information, applicable premarket authorization or exemption support, QMSR records, labeling and UDI records, complaint and MDR procedures, and technical or performance documentation appropriate to the device.

Yes, provided applicable FDA requirements are met. For foreign manufacturers these commonly include establishment registration, device listing, a U.S. Agent, applicable QMSR requirements, labeling, and any required 510(k), De Novo, PMA, or other marketing authorization.

QSIT was FDA's former Quality System Inspection Technique. FDA stopped using QSIT on February 2, 2026, when the QMSR became effective, and now uses the updated medical device manufacturer inspection process described in Compliance Program 7382.850. Inspection preparation should focus on current QMSR requirements and records.

Selling online does not create an exemption from FDA requirements, but registration depends on the company's regulated activity. A manufacturer, repackager, relabeler, specification developer, or U.S. initial importer may need to register; a domestic distributor that does not manufacture or import devices generally does not register solely because it sells devices online.

Typical information includes the establishment legal name and address, owner/operator and official correspondent information, establishment activities, DUNS information used in the facility record, U.S. Agent details for applicable foreign establishments, and the device or manufacturer information required for the establishment's activity type.

A Unique Device Identifier (UDI) is a standardized identifier used on device labels and packages and, for applicable devices, in FDA's Global Unique Device Identification Database (GUDID). UDI requirements include exemptions, alternatives, and device-specific compliance rules, so applicability should be checked for each product.

Yes. We can manage annual registration review, listing updates, U.S. Agent coordination for foreign establishments, and related compliance support based on your service scope.

Medical device labeling is governed by 21 CFR Part 801 and other device-specific provisions. Requirements vary, but may include device identity, responsible firm information, required directions, warnings or precautions, prescription-device statements where applicable, and UDI information when required.

Yes. We can review the detention or Import Alert basis, identify documentation or corrective-action gaps, coordinate supporting evidence, and assist with a response strategy. FDA determines admissibility and whether a firm or product is removed from an Import Alert.

We provide coordinated support for establishment registration, device listing, U.S. Agent services, labeling review, QMSR support, import issues, and annual renewals so companies can manage related FDA obligations through one compliance team.

Our professional service fee is custom-quoted based on the establishment activity, number of devices, U.S. Agent scope, and any labeling or QMSR work. FDA's separate annual establishment registration fee is $11,423 for FY 2026 through September 30, 2026, and $13,785 for FY 2027 beginning October 1, 2026. Most fee-liable establishments must pay the applicable FDA fee before completing registration.

FDA does not require the U.S. Agent to be a regulatory consulting firm. The designated agent must meet FDA's U.S. Agent requirements, agree to the role, and be able to assist with communications between FDA and the foreign establishment. Many firms choose a professional agent for continuity and regulatory handling.

A U.S. Agent is expected to assist with communications between FDA and the foreign establishment and may be asked to help schedule inspections. Failure to confirm the designation or repeated communication problems can create registration and compliance issues, but consequences depend on the circumstances and are not automatic.

The foreign establishment updates its U.S. Agent information through FDA's FURLS/Device Registration and Listing Module. FDA sends the new U.S. Agent an electronic request to confirm the designation. We can manage the update and confirmation process for clients.

Establishment registration applies to the establishment, not one registration per device. Most manufacturers and processors then list the devices associated with their establishment; U.S. initial importers register and identify manufacturers and imported devices rather than creating manufacturer-style listings.

No. Establishment registration identifies a regulated establishment and its activities. A 510(k), when required, is a premarket submission for a specific device. Depending on the product, a device may instead be exempt from 510(k) or require another pathway such as De Novo or PMA.

Marketplace sales do not change FDA's establishment-registration rules. Whether a seller must register depends on what the company actually does—for example, manufacturing, repackaging, relabeling, specification development, or acting as a U.S. initial importer. Marketplaces and distributors may separately request proof of FDA compliance.

Yes. FDA maintains a public Establishment Registration and Device Listing database that can be searched for releasable registration and listing information. FDA does not issue medical device establishment registration certificates, and registration or listing does not mean FDA has approved, cleared, or endorsed the establishment or device.

Whether a product is a medical device depends on its intended use and the statutory device definition. Certain low-risk general wellness products may fall under FDA's general wellness policy, while disease-related or other medical intended uses can bring a product within device regulation. Classification should be based on the product's actual intended use and claims.

Requirements depend on the purpose and circumstances. Devices imported for commercial distribution are subject to applicable registration and listing rules. Investigational devices may be handled under the IDE framework and can have different registration and listing treatment. Personal-use situations should be evaluated case by case.

A single establishment record can reflect multiple FDA device activities when the facility actually performs them. Each activity must be selected accurately because registration, listing, and importer obligations differ by activity type.

FDA requires annual registration review between October 1 and December 31. If the annual registration is not completed, the establishment's registration will not be current for the next registration year, which can affect imports and compliance until the registration and applicable user-fee requirements are completed.

No. FDA explicitly states that establishment registration, assignment of a registration number, or device listing does not denote FDA approval, clearance, or authorization. Any required premarket authorization must be obtained separately.

Not necessarily. A contract manufacturer registers for its own covered activity. A brand owner that meets FDA's definition of a specification developer, relabeler, repackager, manufacturer, or other registrable establishment may have separate registration and listing obligations based on its actual role.