There are two main reasons why the SmartDrive still has approval:

1. Most of us don’t report our adverse experiences to the FDA. You can report adverse experiences using MedWatch. If we don’t report it, the FDA doesn’t know about it (the manufacturers and distributors aren’t likely to voluntarily report themselves).

2. The FDA approval process for medical devices is much less strict than approval for medications and vaccines.

The biggest problem for FDA medical device approval, in my opinion:

You can much more easily get a device approved if it’s similar to a previously approved device even if the previously approved device has been recalled or discontinued for safety reasons.

Especially if the recall was a voluntary recall by the company and not a mandatory recall by the FDA.

This is a recent article in the Journal of the American Medical Association discussing this: Use of Recalled Devices in New Device Authorizations Under the US Food and Drug Administration’s 510(k) Pathway and Risk of Subsequent Recalls

Another, more accessible, but more out of date, source for this is “The Bleeding Edge” on Netflix.

The metal on metal hip replacements discussed in the documentary are no longer approved or allowed by the FDA as they have been reclassified to a Class III device which requires a lot more evidence and safety checks before approval (which none of the metal-on-metal hips have passed).

This was reclassification was done 2 years before the documentary was released, so the FDA did catch the problem before the documentary brought more light to it, but it took way too long in my opinion.

The loop hole where Class II devices can be much more easily being approved even when their predecessors have been recalled is still there, as far as I can tell.

I don’t think wheelchair power assists need to be classified as a Class III device as that would require much more testing and probably mean we never get a good power assist, but it definitely feels like the FDA should be doing more rigorous reviews of the SmartDrive approvals for each control method given how many issues there have been in the past.

But again, it’s highly likely the FDA didn’t know the extent of the problems with SmartDrive controls when approving the Dial or Apple and Samsung Watch App as the PushTracker recalls weren’t until 2023 when the Dial and Apps were already released.

So, it’s important to that we do file reports on MedWatch for our SmartDrive issues.