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FDA 510k Executive Summary A 510k Summary provides a brief summary of the device included in the premarket notification and the supporting information. It must be in sufficient detail to provide an understanding of the basis for a determination of substantial equivalence.

The response should include: submitter's name; 510(k) number; identification of the submission as Additional Information (AI) to the 510(k); date of the FDA's request for additional information; and. the requested information in an organized manner.

The response should include: submitter's name; 510(k) number; identification of the submission as Additional Information (AI) to the 510(k); date of the FDA's request for additional information; and. the requested information in an organized manner.

Indications for Use Statement (FDA Form 3881) FDA Form 3881 is a document where you should identify and describe the indications for use statement for the device(s) included in the 510(k) submission.

If you do not have this information, you should obtain it prior to proceeding. Classification of your device. Predicate device(s) Final draft labeling. Specifications including engineering drawings, photos, etc. Performance data such as bench, animal, or clinical testing (if applicable)

A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate. the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.

A 510(k) is a submission containing information required under 21 CFR 807.87. All 510(k)s are based on the concept of substantial equivalence (SE) to a legally marketed device, also referred to as a predicate. All 510(k)s provide a comparison between the device to be marketed and the predicate device or devices.

A 510k Cover Letter needs to include the administrative information that is needed to properly identify you, your company, the 510k submission type, applicable regulations, product classification, the review panel, the device product code, and any previous submissions related to this 510k submission.