Get the free Request for facility site name or owner change for existing AFlN - adeq state ar
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This document is used to request a change of facility site name or owner for an existing AFlN, specifically detailing current and new site information.
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How to fill out request for facility site
How to fill out Request for facility site name or owner change for existing AFlN
01
Obtain the Request for Facility Site Name or Owner Change form.
02
Provide the current AFlN (Alternate Facility Identification Number) in the designated field.
03
Fill in the existing facility site name or owner's name.
04
Enter the new facility site name or owner's name that you want to change to.
05
Include any necessary contact information for the new owner or facility.
06
Attach relevant documentation proving ownership or authority to make the change.
07
Review the form for accuracy and completeness.
08
Submit the completed form to the appropriate regulatory authority.
Who needs Request for facility site name or owner change for existing AFlN?
01
Facility owners or operators wishing to update their facility name or ownership.
02
Organizations involved in the regulation or oversight of facilities.
03
Legal representatives acting on behalf of the facility owner.
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People Also Ask about
How to transfer ownership of a 510k?
The guidance states that when a 510(k) clearance for a specific device is sold or transferred from one person to another, the new 510(k) holder must list their device in the FDA Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM), within 30 days of the transfer.
What is a transfer of 510k ownership?
The guidance states that when a 510(k) clearance for a specific device is sold or transferred from one person to another, the new 510(k) holder must list their device in the FDA Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM), within 30 days of the transfer.
How do you turn someone into the FDA?
If they choose not to report, or if you'd rather file the report yourself, you may use one of these methods: Online: Use the interactive form at FDA Form 3500. Fax: Get the form (as above) and fax to 1-800-FDA-0178. Phone: Call 1-800-FDA-1088 Monday-Friday between 8 a.m. and 4:30 p.m. EST.
What are the requirements for FDA relabeler?
Regulatory Requirements for FDA Relabelers At a minimum, an FDA relabeler must: Register their establishment as a relabeler with the FDA under 21 CFR Part 807. List each medical device they relabel in the FDA's Device Registration and Listing Database.
What is an official correspondent FDA?
The FDA requires any foreign manufacturer who intends to sell their products in the United States of America (USA) to retain a US Agent with a physical address within the USA. An Official Correspondent is someone designated with the responsibility for communicating with FDA.
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What is Request for facility site name or owner change for existing AFlN?
It is a formal application made to update the official name or ownership details of a facility associated with an existing AFlN (Alternative Facility Identifier Number).
Who is required to file Request for facility site name or owner change for existing AFlN?
The current facility owner or authorized representative is required to file this request to ensure accurate records are maintained.
How to fill out Request for facility site name or owner change for existing AFlN?
The form should be filled out with the existing AFlN, the current facility name, the new facility name or owner information, and any supporting documentation as required.
What is the purpose of Request for facility site name or owner change for existing AFlN?
The purpose is to ensure that the information in regulatory databases is up-to-date, preventing potential confusion and ensuring compliance with relevant regulations.
What information must be reported on Request for facility site name or owner change for existing AFlN?
The request must report the existing AFlN, the current facility name, details of the new owner or facility name, contact information, and any required signatures from the authorized representatives.
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