When a device is upgraded from previous model does it require total FDA evaluation or only upgraded parts needs to be re evaluated.
I think it depends on what type of upgrade you are looking for. From my work experience with Innodisk which is a company manufacture SSD and DRAM. One of the vertical we focus on is a medical market, and one of the requirement to upgrade a medical device with our SSD is required to go through FDA approval. Even it's not going to affect the device performance. it is just a data storage but since these work dependant on different FW based on the controllers. different systems react differently. So, after speccing in the project and run testing they apply for FDA approval. Also, we have our own series of medical vertical.
According to FDA's regulation, a premarket notification must be submitted to FDA when there is
(a) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.
(b) A major change or modification in the intended use of the device.
Any guidance on 510(k)s for changes to a legally marketed device should consider the role the Quality System (QS) regulation plays in changes to devices. For some types of changes to a device, the FDA believes that submission of a new 510(k) is not required and that reliance on existing QS requirements is the least burdensome approach to reasonably assure the safety and effectiveness of the changed device.Regardless of whether a change requires premarket review, the QS regulation requires manufacturers of finished medical devices to review and approve changes to device design and production and document changes and approvals in the device master record. Any process whose results cannot be fully verified by subsequent inspection and testing must be validated, and changes to the process require review, evaluation, and revalidation of the process where appropriate
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)"
