Special 510(k)

The "Special 510(k): Device Modification" utilizes the design control requirement of the Quality System Regulation (21 CFR 820) and may be submitted for a modification to a device that has been cleared under the 510(k) process. The Special 510(k) allows the manufacturer to declare conformance to design controls without providing the data. While the basic content requirements of the 510(k) (21 CFR 807.87) remain the same, this type of submission should also reference the cleared 510(k) number and contain a "Declaration of Conformity" with design control requirements.

Manufacturers of preamendments devices may also submit Special 510(k)s. When the legally marketed (unmodified) device is a preamendments device, the submitter should clearly state that the device is a preamendments device, is legally marketed, and has not been the subject of Premarket Notification 510(k) clearance.

Criteria for a Special 510(k)

To optimize the chance that a Special 510(k) will be accepted and promptly cleared, 510(k) submitters should evaluate each modification to insure that the particular change does not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

Intended Use

Modifications to the indications for use of the device or any labeling change that affects the intended use of the device will not be accepted as a Special 510(k). Therefore, FDA recommends that submitters of Special 510(k)s highlight 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).

Also a change in the labeling 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.

Fundamental Scientific Technology

Special 510(k)s also will not be accepted for modifications that have the potential to alter the fundamental scientific technology of the device. These types of changes generally include modifications to the device's operating principle(s) or mechanism of action, such as automation of a manual device or incorporation of a sensing or feedback circuit. Specific examples that illustrate these types of changes that alter the fundamental scientific technology and thus should not be submitted as Special 510(k)s include:

1. A change in a surgical instrument that uses a sharpened metal blade to one that cuts with at a laser;
2. A change in an in vitro diagnostic (IVD) device that uses immunoassay technology to one that uses nucleic acid hybridization or amplification technology;
3. Incorporation of a sensing mechanism in a device to allow the device to function "on demand" rather than continuously.

Device modifications that should be appropriate for review as Special 510(k)s also include those changes identified below:

• Energy type
• Environmental specifications
• Performance specifications
• Ergonomics of the patient-user interface
• Dimensional specifications
• Software or firmware
• Packaging or expiration dating
• Sterilization

Clinical Considerations

Collection of clinical data to support a Special 510(k) may require submission of an Investigational Device Exemptions (IDE) application to FDA. The fact that a significant risk device investigation was conducted to support any of the activities listed above, however, does not necessarily preclude the submission of a Special 510(k).

Manufacturers who intend to conduct clinical investigations of a modified device as part of design validation are encouraged to contact the appropriate ODE review division before preparing a Special 510(k).

If FDA determines that a Special is not eligible for review as submitted, the FDA reviewer will notify the firm of this decision and offer the option of having the document converted to a Traditional 510(k) or withdrawing it for future submission.

Related Training:

How to Prepare a 510(k) FDA Submission
How to File a 510(k) When your Device is (or contains) Software
Construct a 'Real' 510(k) Submission: From Start to Finish