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The 510(k) is not a form. The information should be provided in an organized, tabulated document. The 510(k) should provide sufficient detail for FDA to be able to determine that the device is substantially equivalent (SE) to another similar legally marketed device(s).When does FDA make a 510 (k) summary of safety and effectiveness?
According to CFR 21 Part 807.95 (d) “ FDA will make a 510 (k) summary of the safety and effectiveness data available to the public within 30 days of the issuance of a determination that the device is substantially equivalent to another device. ” That means the summary document you created will be out there for everyone to see.Do I need to provide performance data for my 510 (k) application?
Most 510 (k)s will include some type of performance data. The extent of performance data will depend on the complexity of the device and its intended use and indications. Performance data should be provided to help demonstrate SE of your device to one or more legally marketed devices (predicate device).Can a new 510K be submitted for an existing device?
Submission of a New 510 (k) for a Change to an Existing Device There are no provisions for a 510 (k) amendment or supplement to the existing 510 (k).If it is determined the modification is not covered by the current 510 (k) a new 510 (k) must be submitted.