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)"
FDA reevaluation depends on the type and impact of the change to the product. Not all upgrades require a full FDA review, but some upgrades do. Basically, if a change could affect safety or its intended use, a new 510(k) is usually required, but minor changes could be handled through internal testing and quality control systems. Essentially, the FDA asks: Does the change significantly affect the device? If yes, a reevaluation is needed. If not, a reevaluation may not be needed.
When it comes to the upgrading of a device and the documentation of said device, I think that it doesn't need to be completely refiled and instead can have documentation of the devices upgrades and the testing that has gone on to prove the effectiveness of the device now. The reason for this as a lot the ground work for the device has already been laid out and all the proper documentation has been done the first time and has proven its safeness and effectiveness. But if the upgrade completely alter the integrity of the device, then it need to prove that it is more effective and just as safe if not more safe than the original device. By doing so this allow for the device to be tested with the upgrades made to it, and allows for less time of it having to be filed for paper work and proving of the device as it already has the ground work laid in front of it.
I was a bit confused on the wording of this post but I'm assuming you meant making modifications to a previously existing medical device. From my understanding, the FDA does not require a total re-evaluation of a device in that sense and mainly focuses on what the upgrade to the device entails. The only reason for a total re-evaluation of a device would be if the upgrade fundamentally changes the function or the overall purpose/intended use of the device. Minor changes to the device likely would not constitute FDA notification and could just be update via internal documentation. This would be features like a faster processor for a medical device which doesn't effect user risk or outputs of the device. This may be subject for FDA review, but would not cause a re-evaluation of the device. Significant upgrades such as changing intended use of the product would require a new submission, and this can be either 510(k) or a PMA depending on the risk it poses to the user or if it is substantially equivalent. To further the direction of this discussion I pose a question:
Your team works on a smart insulin pump, and they want to upgrade the device to allow it to connect to a smartwatch. How would you treat this upgrade? Would it be an internal documentation change, or a new FDA submission?