Frequently Asked Questions

Does your software device qualify for a special 510(k) submission?

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Compliance & Regulatory: MedTech

For a premarket submission to qualify for review under the Special 510(k) Program, the device should be a modification of your 510(k) cleared device that you own, where the modification does not alter the intended use or the fundamental scientific technology of the device. In a Special 510(k), you should follow the recommendations in this guidance on the documentation to submit, but submit only the documentation related to the modification that prompted the submission. For example, when submitting the documentation of requirements and specifications in a Special 510(k), the documentation should focus on the modifications and may not necessarily include all of the requirements and specifications of the entire device.

FDA recommends that you submit the regression testing performed to verify and validate the modifications. It is also recommended that you submit your test plans, pass/fail criteria, and summary results rather than test data. In all cases, the type of software-related documentation and the level of detail you provide should be appropriate to the Level of Concern associated with your device in the context of the modifications. Since a Special 510(k) submission relies on your declaration of conformance to design controls, you cannot properly submit a Special 510(k) until you have completed testing or other activities relied on by your declaration.