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Introduction
The 510(k) regulation is found in 21 CFR 807 Subpart E and includes information required in a 510(k). 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). Some sections will contain only one page; others may contain 50 or more pages. The average 510(k) is about 35 pages; others may run to 100 or more depending on the complexity of the device. For any device, the 510(k) is formatted essentially the same way and contains the same basic information (required elements).
This section is a general guide for all 510(k)'s. Please review the appropriate information for the type of 510(k) you will submit: Traditional, Special, or Abbreviated 510(k)s.
The 510(k) submitter should prepare and submit a complete application in order to obtain marketing clearance. To facilitate FDA review of the data, analysis, and conclusions in the application, the manufacturer should check for the:
A description of the tests and the results obtained are essential. Reasonable and sufficient details of all test procedures and results should be submitted to FDA. The following suggestions will help assure that your application is complete.
Important Note: In order to address the required elements, you will need the following information to assure that your 510(k) is complete. If you do not have this information, you should obtain it prior to proceeding.
The 510(k) regulation is found in 21 CFR 807 Subpart E and includes information required in a 510(k). 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). Some sections will contain only one page; others may contain 50 or more pages. The average 510(k) is about 35 pages; others may run to 100 or more depending on the complexity of the device. For any device, the 510(k) is formatted essentially the same way and contains the same basic information (required elements).
This section is a general guide for all 510(k)'s. Please review the appropriate information for the type of 510(k) you will submit: Traditional, Special, or Abbreviated 510(k)s.
The 510(k) submitter should prepare and submit a complete application in order to obtain marketing clearance. To facilitate FDA review of the data, analysis, and conclusions in the application, the manufacturer should check for the:
- logical presentation of the data;
- scientific soundness of the test and data analysis;
- relevance of the test program to the device and the intended use; and
- completeness of the summary report of the tests or studies.
A description of the tests and the results obtained are essential. Reasonable and sufficient details of all test procedures and results should be submitted to FDA. The following suggestions will help assure that your application is complete.
- Understand the FDA decision-making process. The decision process is discussed in The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)]
- Obtain and use the right guidance. FDA provides many device specific guidance documents for the preparation of marketing applications.
- Use the CDRH Premarket Review Submission Cover Sheet and the Screening Checklist for all Premarket Notification 510(k) Submissions to prepare your submission. The cover sheet is a "fill-in-the-blank" format which satisfies many of the 510(k) requirements. The checklist will assure that all required elements are provided.
Important Note: In order to address the required elements, you will need the following information to assure that your 510(k) is complete. 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)
- Sterilization information (if applicable)
- Guidance document(s) specific to your device type, if it exists
It is not a requirement that you organize your 510(k) into the following labeled sections, you may make modifications in order to meet the specific needs of your device. The following is a brief discussion of the required elements.