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DEPARTMENT OF HEALTH AND HUMAN SERVICES 1. REGISTRATION NUMBER FORM APPROVED: OMB No. 0910-0387 EXPIRATION DATE: April 30, 2008 2. OWNER/OPERATOR NUMBER VALIDATION (FDA USE ONLY) FOOD AND DRUG ADMINISTRATION

How to fill out registration of device establishment

How to fill out registration of device establishment:

1. Gather all necessary information: Before starting the registration process, make sure you have all the required information at hand. This may include the device's specifications, intended use, manufacturing details, and any relevant clinical trial data.
2. Access the registration form: Find the appropriate registration form provided by the regulatory agency responsible for device establishment registration. This form can usually be accessed from the agency's website or through a designated portal.
3. Complete the general information section: Start by filling out the general information section of the registration form. This typically requires providing details such as the company name, establishment address, and contact information.
4. Provide device information: Next, provide all necessary details about the device being registered. This may include the device name, model number, intended use, classification, and any applicable product codes.
5. Include manufacturing details: If the device is manufactured in-house, provide information about the manufacturing processes, quality control measures, and any applicable certifications or accreditations. If the device is manufactured by a third party, include details about the contracted manufacturer.
6. Submit clinical data (if required): Depending on the nature of the device, you may need to provide relevant clinical trial data or other scientific evidence to support its safety and efficacy. Ensure that all required documents are properly compiled and included.
7. Provide additional supporting documents: Check if any additional supporting documentation is required, such as labeling information, sterilization validations, or instructions for use. Include these documents as necessary.
8. Review and submit the registration form: Once you have completed all sections of the registration form and attached the required documents, review the form for any errors or omissions. Make any necessary corrections before submitting the form to the regulatory agency.

Who needs registration of device establishment?

1. Manufacturers: Manufacturers of medical devices generally need to register their establishment with the appropriate regulatory agencies. This registration process ensures that the manufacturing facility meets the necessary quality standards and regulatory requirements.
2. Importers: Importers of medical devices are often required to register their establishment as well. This allows regulatory authorities to track and monitor the importation of devices to ensure compliance with safety and quality standards.
3. Distributors: In some cases, distributors or suppliers of medical devices may also need to register their establishment. This requirement helps to ensure that devices are being distributed through authorized channels and that the distributor meets necessary regulatory obligations.
4. Other stakeholders: Depending on the jurisdiction or specific regulations, other stakeholders such as contract manufacturers, re-packagers, and re-labelers may also be required to register their establishment. It is important to consult the relevant regulations to determine the specific requirements for each stakeholder.

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What is registration of device establishment?

Registration of device establishment is the process of submitting information about a facility that manufactures, prepares, propagates, compounds, assembles, or processes devices intended for marketing in the United States.

Who is required to file registration of device establishment?

All establishments engaged in the production or distribution of medical devices intended for commercial distribution in the United States are required to file registration of device establishment.

How to fill out registration of device establishment?

Registration of device establishment can be filled out online using the FDA Unified Registration and Listing System (FURLS) or by submitting a paper form FDA 3673.

What is the purpose of registration of device establishment?

The purpose of registration of device establishment is to provide the FDA with information about the location and activities of medical device manufacturers to ensure compliance with regulations and facilitate inspections.

What information must be reported on registration of device establishment?

Information that must be reported on registration of device establishment includes the name and location of the establishment, activities conducted, types of devices manufactured or distributed, and contact information for the responsible official.