After being draft for months, last October the FDA finally issued two guidances for handling changes to devices registered or notified with the FDA:
– “Deciding when to submit a 510(k) for a change to an existing device” on Medical Devices;
– “Deciding when to submit a 510(k) for a software change to an existing device” on medical software.
With the official release of these two documents, the FDA updated the requirements set out in the “Deciding when to submit a 510 (k) for a change to an existing device (K97-1)” guidance published in 1997.
In some cases, following changes to Medical Devices and/or medical software, the FDA requires a new 510(k). In this regard, the US Authority issued these two new guidances in order to better clarify the cases in which a new 510(k) procedure is needed and which documentation must be attached to the submission.
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