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What actions should you take if the change is made solely to return the system into specification of the most recently cleared device?
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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.

When a change to the software only restores the device to the specifications of the most recently cleared device, then submission of a new 510(k) is likely not required. Generally, it is unlikely that modifications to software solely to restore the device to the most recently cleared device’s specifications could significantly impact safety, effectiveness, or intended use of the device; however, manufacturers should evaluate the impact of the software changes. Manufacturers should conduct an analysis that involves determining the overall impact of the change to the device in terms of risk assessment and performance. This analysis is important for evaluating any modification that adds new features that appeared in the specification of the most recently cleared device but were not yet implemented.

Missing, incomplete, ambiguous, or conflicting software requirements may lead to a software modification that involves updating specifications, resulting in additional software code changes. In these situations, the answer to this question is likely that a new 510(k) is unnecessary.

Generally, manufacturers are not required to submit a new 510(k) for changes to a specification document to clarify to an existing software requirement or to capture a missing software requirement, provided that this does not necessitate any changes to software code or product performance specifications. However, manufacturers should still assess the impact of the changes on other software documentation when applying appropriate design controls.

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