Special 510(k)- Content/Format

A Special 510(k) should be well organized and formatted in sections, with page numbering, and include the required elements:

Medical Device User Fee Cover Sheet (Form FDA 3601)
CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)
Certification of Compliance with ClinicalTrials.gov Data Bank, FDA-3674
Cover Letter, clearly identifying the application as a "Special 510(k)." Include 510(k) holder name, address, and facility registration number, if available.
Table of Contents (recommended)
510(k) Screening Checklist (recommended)
Statement of Indications for Use
(k) Summary [21 CFR 807.92] or 510(k) Statement [21 CFR 807.93]
Data Report for 510(K)s - FDA 3654 [PDF] Submit this form if your 510(k) references a national or international standard.
Truthful and Accuracy Statement
Class III Certification and Summary (if applicable)
The name of the legally marketed (unmodified) device and the 510(k) number under which it was cleared. Include the trade or proprietary name, if any, and the common or usual name or classification name of the device. Provide the classification of the device, appropriate panel (e.g. cardiovascular, dental, etc.), and product code, if known.

In cases where the referenced 510(k) was submitted under a different name than that of the submitter of the Special 510(k), FDA recommends that a statement to this effect be included in the Special 510(k) and that the submitter maintain adequate information demonstrating his legal right to distribute the device.

Items required under §807.87 (Information required in a Premarket Notification submission), including

description of the modified device; where applicable, photographs or engineering drawings should be supplied,
comparison to the cleared device indicating similarities and/or differences accompanied by data, as appropriate; this information may include an identification of materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device.
intended use of the device,
proposed label, labeling, and advertisements for the device and directions for use. It is recommended that submitters of Special 510(k)s highlight, or otherwise prominently identify, all changes in the proposed labeling that may result from modifications to their legally marketed device. In addition, it should be clearly stated in the Special 510(k) that the intended use of the modified device, as described in its labeling, has not changed as a result of the modification(s). Please note that a labeling change from prescription use to over the counter use, or vice versa, is considered a change in intended use and, therefore, is not eligible for the Special 510(k) method.

A concise summary of the design control activities. FDA may consider the information generated from these activities to be "appropriate supporting data" within the meaning of §807.87(g). This summary should include the following:

An identification of the Risk Analysis method(s) used to assess the impact of the modification on the device and its components as well as the results of the analysis;
Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and the acceptance criteria applied; and
A declaration of conformity with design controls that includes:
A statement that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met; and
A statement that the manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. If a recent Quality System inspection has resulted in the issuance of a violative inspection report, the manufacturer should be prepared to describe those corrective actions taken, if needed, that form the basis for the declaration of conformity.