H.R. 71, Accelerating IVD Failures

Is the FDA’s role in ensuring effectiveness of Invitro Diagnostic Devices important?

Some don’t believe so. However, my career began with some wise and experienced people educating me on the history our Food, Drug, and Cosmetic Act.

So here is where I am coming from:

1. I do believe that misdiagnosis and incorrect data results in missed opportunities to heal and even save lives,
2. I do believe that there have been, are, and always will be people who are na?ve to, or even skirt best practices as they chase dollars,
3. I do believe that the more people we have on this earth (and there is more today than ever) the more likely such people will be encountered, and
4. All we need is one to have people hurt.

That said, Andy Biggs (R-AZ) introduced a bill on January 9th to exempt noninvasive diagnostic devices (those that don’t penetrate a bodily membrane) from the regulatory authority of the Food and Drug Administration (FDA).

I suspect that the intent was to allow the Apple? watch, for example, to do whatever it wants without Apple? having to prove themselves to anyone. But if such a device is deserving of less scrutiny, there is a process for that already in place. Many devices have been deemed to need little to no oversight. These are Class I, GMP Exempt. ?I’m not saying I believe this watch example deserves that or not, only that there is a process.

As technology progresses, more and more devices will be called noninvasive diagnostic devices, but the importance of these devices will not decrease. I also know from experience that if H.R. 71 passes into law it would attract people who are happy to not be scrutinized. These are not people we want making devices we rely on.

Completely removing all influence of the FDA over a group of devices defined so broadly is like banning the town’s Sherriff from a whole neighborhood because we think that neighborhood is safe enough.

(This bill is referred to as the Medical Innovation Acceleration Act of 2023)