What the FDA considers a Prescription Device - Decisions and Implications

[Mark Meer]

Re: Prescription Devices - Decisions and Implications

Finger SpO2 monitor is a Rx device

Is it? From your description, I assume the reason is because of the potential of not knowing what to do with the readings? Going back to the definition of prescription device:

"...harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe except under the supervision of a practitioner licensed by law to direct the use of the device...."

In this case, and by this definition, I don't see why the device would be designated as prescription only...
Sure, direction by a physician may help optimize the device's use, but I don't see any evidence that the device is "not safe except under the supervision of a practitioner".

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If Finger SpO2 monitors are prescription only devices, I presume blood-glucose meters and blood-pressure monitors would also be Rx Only, for the same reason?

If so, there appears to be a disconnect between regulation and enforcement. Any of these devices can be readily purchased (from US distributors), with no concerns for a "practitioner licensed by law" to direct or administer them...

 

[MIREGMGR]

Re: Prescription Devices - Decisions and Implications

I don't have specific knowledge of the marketing status of finger SpO2 monitors, but I'd think the limitation in marketing such devices to lay persons would be in writing the instructions for use...particularly in regard to interpretation and meaning of results, which might require quite a bit of medical teaching in the IFU to guide the lay user to not misunderstand the test result in any conceivable patient circumstance where they might apply the device.

That's true, of course, of any device that performs a diagnostic function that's medically complex.

The "safety" requirement exists, but it's not the only requirement. The difficult one is the general requirement, for all devices except those that are marketed only to qualified professional users that have pre-existing knowledge of their correct use, for provision of "adequate" instructions for use. FDA has (in my view, anyway) consistently interpreted "adequate" in regard to an IFU intended for lay users of a diagnostic device to mean that the IFU makes it substantially unlikely that a lay user will mis-use the device in a way that causes them to make an incorrect diagnosis.

 

[somashekar]

Re: Prescription Devices - Decisions and Implications

THIS new draft guidance from FDA about General wellness: Policy for low risk devices., I felt is relevant to this discussion here.

 

[Ronen E]

Re: Prescription Devices - Decisions and Implications

THIS new draft guidance from FDA about General wellness: Policy for low risk devices., I felt is relevant to this discussion here.

Document issued on: January 20, 2015

Can I please have a ride on your time machine?

 

[somashekar]

Re: Prescription Devices - Decisions and Implications

Can I please have a ride on your time machine?

I did see that....That's FDA for you ... Always ahead

 

[Mark Meer]

...I'd think the limitation in marketing such devices to lay persons would be in writing the instructions for use...

Ok, so just to clarify, given a hypothetical device that is safe for use by a layperson, the only implication of then designating it prescription (because the predicate is) is the additional requirement for an "Rx Only" designation/statement in the labelling?

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On a slightly tangential point of discussion regarding the draft guidance link posted:

Aside from the issuance date being in the future (as already pointed out), does anyone else get the impression that this serves only a legal-liability purpose more than addressing public-safety?

For example, I can't claim that my device helps obese people, but I can claim that it is intended to "maintain a healthy weight" or "assist with weight loss goals"?? ...gee, with those kinds of claims, I wonder who is going to be using the device a lot...obese people?

 

[Sheila1]

Re: Prescription Devices - Decisions and Implications

Hi Everyone!

What if you have a Class I device where you can't view the predicates? How do you know if it needs to be sold as Rx only?

Thanks!

 

[Mark Meer]

Re: Prescription Devices - Decisions and Implications

What if you have a Class I device where you can't view the predicates? How do you know if it needs to be sold as Rx only?

Nearly all Class I devices are 510(k) exempt, so I don't know that it's as important that you compare to a predicate.

I think, in such cases, the determination is up to you.
Use the definition:

A prescription device is, by definition under 21 CFR 801.109, a device which, because of any potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe except under the supervision of a practitioner licensed by law to direct the use of the device, and hence for which "adequate directions for use" (21 CFR 801.5) cannot be prepared."

Additionally, you could investigate other similar devices:
If you know the 3-letter FDA product for your device, use the FDA's Establishment Registration & Device Listing search to search by product code. This will bring up a list of devices with the same code, and you can go to their website and see...

Just some suggestions...
MM

 

[Sheila1]

Re: Prescription Devices - Decisions and Implications

That's a great idea. Thanks!