-
zbw2 replied to the topic FDA about upgraded device in the forum Introduction to Project Management 7 years, 2 months ago
to follow up on what was posted above, for software updates, which may seem trivial, device approval is based on if the update “could significantly affect the safety or effectiveness of the device”. an excerpt of this FDA guidance publication states
“If a manufacturer modifies their device with the intent to significantly affect the safety or
effectiveness of the device (for example, to significantly improve clinical outcomes, to
mitigate a known risk, in response to adverse events, etc.), submission of a new 510(k) is
likely required. A change intended to significantly affect the safety or effectiveness of the
device is considered to be a change that “could significantly affect the safety or
effectiveness of the device” and thus requires submission of a new 510(k)”
