Special 510(k) for software change

  • Thread starter Elizabeth Rafferty
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Elizabeth Rafferty

We have updated the software for our medical device and we are preparing a special 510(k). Our software was determined to be of moderate concern. Are we required to provide all the elements listed in "Content of Premarket Submissions for Software contained in a medical device" in a special 510(k)?

Ronen E

Problem Solver

The guidance document you mentioned includes the following, which answers your question:

The Special 510(k) Program

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 devicevii . 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.
We recommend that you submit the regression testing performed to verify and validate the modifications. We recommend 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, we believe you cannot properly submit a Special 510(k) until you have completed testing or other activities relied on by your declaration (see section 514(c)(1)(B) of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. 360d(c)(1)(B)).

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