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SPECIAL 510(k): Device Modification ODE Review Memorandum (Decision Making Document is Attached) To: RE: THE FILE DOCUMENT NUMBER K091949 This 510(k) submission contains information/data on modifications
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What is special 510k device modification?
Special 510k device modification refers to changes made to a medical device that may affect its safety and effectiveness, but do not require a new premarket submission.
Who is required to file special 510k device modification?
Manufacturers of medical devices that have received FDA clearance for a 510k submission are required to file a special 510k device modification.
How to fill out special 510k device modification?
To fill out a special 510k device modification, manufacturers must provide detailed information about the changes made to the device and their impact on safety and effectiveness.
What is the purpose of special 510k device modification?
The purpose of special 510k device modification is to ensure that changes made to a medical device do not compromise its safety and effectiveness.
What information must be reported on special 510k device modification?
Manufacturers must report detailed information about the changes made to the device, as well as any testing or data that supports the safety and effectiveness of the modified device.
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