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Does your software device qualify for a special 510(k) submission?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

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.

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