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510(k) Premarket NotificationOrtho Organizers Inc. Ceramic Brackets 1 920115.510(k) Summary14V110335 510k Summary Device Name:Ceramic BracketsSubmitter\'s Name, address, telephone number, contact
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21 cfr80792 - content is needed by any entity or individual involved in the registration process of medical devices under the FDA's regulations.
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This includes manufacturers, importers, distributors, and any other party seeking to market a medical device in the United States.
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Compliance with 21 CFR 807.92 is mandatory for those who fall under its scope.
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21 CFR 807.92 outlines the content requirements for the 510(k) premarket submission for medical devices to the FDA. It specifies the information that must be provided to demonstrate that a device is safe and effective.
Manufacturers and importers of medical devices who intend to market their products in the United States are required to file a 510(k) submission that includes the information specified in 21 CFR 807.92.
To fill out 21 CFR 807.92 content, manufacturers must compile a 510(k) submission that includes administrative information, device description, substantial equivalence comparison, intended use, and performance testing data, among other required details.
The purpose of 21 CFR 807.92 is to ensure that the FDA receives adequate information to evaluate the safety and effectiveness of new medical devices before they can be marketed.
The information required includes the device name, type, intended use, description, labeling, performance testing data, and any other relevant data that supports the substantial equivalence claim.
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