FDA Medical Device Establishment Registration & Listing

FDA Medical Device Establishment Registration & Listing

Medical device establishments involved in the manufacture, processing or distribution of devices intended for commercial distribution in the United States may be required to register with the US Food and Drug Administration (FDA) and list applicable devices. These requirements help the FDA identify establishments and the medical devices associated with their activities.

Cosmetic Compliance Nest provides FDA establishment registration and device listing support to help eligible businesses organise their information and navigate the applicable registration process. Whether you are preparing for initial registration or reviewing an existing registration, we help you understand the relevant requirements and documentation.

What Is FDA Establishment Registration?

FDA establishment registration is the process through which a medical device establishment provides required information to the FDA about its location, ownership or operator and regulated activities. Establishments subject to registration requirements must submit their information electronically unless the FDA grants an applicable waiver.

Registration is generally an annual obligation. Most establishments required to register must also list the medical devices they manufacture or process and identify the relevant activities performed at each establishment.

What Is Medical Device Listing?

Device listing provides the FDA with information about applicable medical devices associated with an establishment. Depending on the establishment's role and the device, the listing may include the proprietary device name, product code, relevant premarket submission number and activities performed at the facility.

Device listing requirements depend on the type of establishment and its activities. A device that requires FDA marketing authorization generally cannot be listed for commercial marketing until the applicable authorization requirements have been met.

What Is Included in Our Service?

• Initial registration support: Guidance for eligible establishments preparing their initial FDA registration.
• Establishment information review: Assistance reviewing legal business name, facility address, contact details and relevant ownership or operator information.
• Device listing support: Help organising device names, product codes, activities and other applicable listing information.
• Premarket information review: Guidance on identifying relevant 510(k), De Novo, PMA or other submission information where applicable.
• Foreign establishment guidance: Assistance understanding relevant requirements for foreign establishments, including US Agent designation where required.
• Registration process guidance: Support navigating the applicable FDA electronic registration and listing system.
• Information consistency review: Help identifying apparent omissions or inconsistencies in the information provided.
• Submission status guidance: Assistance reviewing available confirmation or registration status information within the agreed service scope.

Who May Need FDA Registration and Listing?

Depending on their activities and applicable exemptions, the following types of establishments may be subject to FDA registration and listing requirements:

• Medical device manufacturers
• Foreign medical device manufacturers exporting devices to the United States
• Contract manufacturers and contract packagers
• Specification developers
• Repackers and relabellers
• Remanufacturers and certain other regulated establishments
• Initial importers and other establishments subject to specific registration requirements

Requirements vary by establishment activity. Not every distributor, consultant or business associated with medical devices is required to register or list devices. Eligibility should be assessed against the FDA's applicable rules.

Initial Registration vs. Existing Registration

Initial Registration

Businesses registering for the first time may need to establish the appropriate FDA account, identify the owner or operator and official correspondent, provide facility details, create applicable device listings and complete the required fee and submission steps.

Existing Registration

Already registered establishments should use their existing FDA account to review or update registration and listing information. Creating a duplicate account or registration can cause delays and access problems.

FDA Registration and Listing Process

1. Initial assessment: We review your establishment's activities, location and intended US market activities.
2. Information collection: We identify the company, facility and device information needed for the applicable process.
3. Requirement review: We help identify relevant registration, listing, fee and US Agent requirements, where applicable.
4. Registration preparation: We help organise the information for submission through the appropriate FDA system.
5. Submission and confirmation: The registration is submitted through the applicable process, with confirmation reviewed when available.

Documents and Information Required

The information required depends on your establishment type and whether you are applying for initial registration or updating an existing record. You may need to provide:

• Legal company name and establishment address
• Owner or operator details
• Official correspondent contact information
• Establishment activities and device manufacturing or processing details
• Device names and relevant product codes
• Applicable 510(k), De Novo, PMA or other marketing authorization details
• US Agent information for foreign establishments, where required
• Existing FDA registration or listing information, if available
• Applicable annual registration fee payment details

FDA Fees and Regulatory Responsibilities

Most establishments required to register must pay the applicable annual establishment registration user fee. The amount is set by the FDA for the relevant fiscal year and may change. Some limited fee waivers may be available under specific FDA programmes and criteria.

Registration and listing are not the same as FDA clearance or approval. If a device requires premarket authorization, the relevant requirements must be satisfied separately. Establishments must also meet their other applicable regulatory obligations.

Why Choose Registration Support?

• Understand which registration and listing requirements may apply to your establishment.
• Organise business and device information before submission.
• Identify apparent information gaps early in the process.
• Review registration and listing details for consistency.
• Plan for annual renewal and future updates.

Frequently Asked Questions

For additional information about eligibility, documentation, fees and the registration process, please visit our dedicated FAQ page or contact Cosmetic Compliance Nest.

Get FDA Registration and Listing Support

Planning to introduce medical devices to the US market or register a foreign establishment? Contact Cosmetic Compliance Nest to discuss your establishment type, device information and registration requirements.