What the FDA considers a Prescription Device - Decisions and Implications

[Mark Meer]

Can anyone enlighten me (or point me to the right regulations/guidances), as to what the FDA considers a prescription device?

Alternative to Certain Prescription Device Labeling Requirements and FDA 21 CFR 801.109 talk about labeling, but I'm still a bit confused.

In particular:

1. Decision: How do you decide if your device is prescription or not? Does the FDA have any guidance, or is it purely up to the manufacturer and their stated intended use?
We are developing a device intended for both home-use (where it can be used safely by anyone), and clinical-use (where there is the expectation that administration of the device will be aided by a clinician or therapist).

2. Sales: What are the sales implications of a prescription device? If we ship direct-to-customer, is there any onus to obtain evidence of a valid prescription prior to sale?
Our device will not be available through storefront retailers. It must be ordered through us or a distributor.

3. Labeling: Is it necessary to mark "Rx Only" on the device itself (e.g. as part of the device label)? ...or is it sufficient to mark on accompanying documents (e.g. instructions for use), and/or the packaging?

4. Labeling (if answer to 3 was 'yes'): If the device has several components and/or accessories, do they all have to be marked "Rx Only"?

As usual, thanks in advance to all regulatory gurus out there that can weigh-in...

 

[Ajit Basrur]

Re: Prescription Devices - Decisions and Implications

Did you refer the Device Labeling Guidance #G91-1 (blue book memo) - http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081368.htm

and refer to Attachment IX for details

 

[Ronen E]

Re: Prescription Devices - Decisions and Implications

Hi Mark,

These are all strategic regulatory questions for a specialist (either internal or outsourced); not so much 2-minute questions for a forum. Regardless, here are some preliminary thoughts on your questions:

1. I think it's best to classify the device(s) first. You might find related requirements / guidance in specific guidance for the specific procode. It's also useful to look at the predicates. Other than that it's up to you. The home-use version and the pro-use version might be considered 2 different devices in regulatory terms. They might even require 2 separate submissions, as the issues might be very different.

2. I think that there are legal requirements related to supply of Rx Only devices direct to the general public (i.e. persons who are not licensed practitioners). This is not directly related to medical devices regulations.

3&4. Rx Only labeling is not different from any other labeling requirement. Follow the general rules and guidelines regarding labeling on and off the actual device.

Cheers,
Ronen.

 

[Mark Meer]

Re: Prescription Devices - Decisions and Implications

Thanks for the replies!

The device is class II.
In clinical settings, we suggest clinician/therapist supervision, simply because they are in a position to optimize the use (i.e select the best settings based on the patient), as well as aiding those with physical or cognitive difficulties.
In otherwords, their involvement is a matter of practicality, and not safety.

This would lead me to think that the device need not be specified as a prescription device.

The predicate we intend to use, however, is a prescription device (ours, however, is much simpler and has more safety controls). ...so I'm a bit concerned about deciding ours is not Rx, just for 510k purposes...

 

[Ronen E]

Re: Prescription Devices - Decisions and Implications

The device is class II.

I meant the ProCode (which might have specific guidance attached to it).

The predicate we intend to use, however, is a prescription device (ours, however, is much simpler and has more safety controls). ...so I'm a bit concerned about deciding ours is not Rx, just for 510k purposes...

It's not that trivial. If the predicate is Rx Only it means that there is some sort of control over its use, that will be absent in your case. Perhaps you need to look for another predicate or even another procode. Otherwise you'll have to substantiate that the additional safety measures are adequate instead of that control.

 

[somashekar]

Re: Prescription Devices - Decisions and Implications

Thanks for the replies!

The device is class II.
In clinical settings, we suggest clinician/therapist supervision, simply because they are in a position to optimize the use (i.e select the best settings based on the patient), as well as aiding those with physical or cognitive difficulties.
In otherwords, their involvement is a matter of practicality, and not safety.

This would lead me to think that the device need not be specified as a prescription device.

The predicate we intend to use, however, is a prescription device (ours, however, is much simpler and has more safety controls). ...so I'm a bit concerned about deciding ours is not Rx, just for 510k purposes...

You will be wide away with FDA, when your predicate device is Rx only and your's is not. Discuss with your reviewer.
By logic, the Rx only information must be on the packaging label and IFU, which can be seen in any transaction, before it is opened and taken to use / or read and understood before use.
Rx only route is safe based on the intended use, more than simplicity and safety of the device.
It looks to me you have concern from the marketing front on this device if it is Rx only. FDA concern is elsewhere.

 

[Mark Meer]

Re: Prescription Devices - Decisions and Implications

Rx only route is safe based on the intended use, more than simplicity and safety of the device.

According the the Blue-book guidance Ajit posted in post#2, prescription devices are defined as follows:
"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...."

The intended use of the predicate (and, I imagine, many Class IIs), don't address any of these criteria explicitly. Without looking at their risk-management decisions, it's difficult to know exactly which of these criteria (if any) led to their Rx Only decision.

It seem a shame that we'd have to declare Rx Only, simply because the predicate is. ...especially because we've put a lot of effort into the risk-management and design to eliminate all the above criteria that define a prescription device.

-----

On another related point of discussion:
How on earth do you apply the statement in the definition: "...is not safe except under the supervision of a practitioner licensed by law to direct the use of the device...." (emphasis added).

I can understand the application to some devices (e.g. surgical devices, diagnostic systems, MRI, X-ray). ...but for most devices, as far as I know, there is no legal licensing program to direct their use.

 

[Ronen E]

Re: Prescription Devices - Decisions and Implications

It seem a shame that we'd have to declare Rx Only, simply because the predicate is. ...especially because we've put a lot of effort into the risk-management and design to eliminate all the above criteria that define a prescription device.

This is what I referred to in saying that these are strategic questions. I don't know how far you are down the submission path, but it sounds like you've at least done a fair amount of preparation work based on that specific predicate. Selecting the right (most effective and most efficient) predicate (and ProCode) upfront is perhaps the single most important step in the 510(k) process and one of the most important in the USA regulatory clearance process in general. It's most important it is done based on a good understanding of how the system works, and the implications. If your device was designed to not be an Rx Only device, I would have looked for a predicate with that status, if still possible and practical.

On another related point of discussion:
How on earth do you apply the statement in the definition: "...is not safe except under the supervision of a practitioner licensed by law to direct the use of the device...." (emphasis added).

I think your parsing (as shown by the emphasis you added) is making it unnecessarily tough for you... It should be: "...under the supervision of a practitioner licensed by law to direct the use of the device..."

The licensing relates to the practitioner's practice, not to the use of the device. A licensed practitioner is required to supervise/direct the use of the device. I think this wording is used to allow scenarios where the practitioner is not directly using the device (himself/herself), but is still in charge (and responsible) of the use.

 

[Mark Meer]

Re: Prescription Devices - Decisions and Implications

<selecting a predicate is> most important it is done based on a good understanding of how the system works, and the implications. If your device was designed to not be an Rx Only device, I would have looked for a predicate with that status, if still possible and practical.

I'm still not understanding why having the same prescription device status as the predicate is essential for 510k.

Can you not conceive of a device that has the same procode, indications for use, technology, materials etc. as an Rx Only predicate, but which is designed in a way that overcomes the risks that previously necessitated administration by a "practitioner licensed by law"?

Personally, I think the prescription status should be assessed case-by-case based on the definition, and not factor into substantial equivalence. ...but maybe that's not the way the FDA sees it.

The licensing relates to the practitioner's practice, not to the use of the device. A licensed practitioner is required to supervise/direct the use of the device. I think this wording is used to allow scenarios where the practitioner is not directly using the device (himself/herself), but is still in charge (and responsible) of the use.

This makes sense, and would my interpretation too, ...but the wording in the guidance is just terrible!

"Licensed by law", makes no sense on its own unless somehow qualified. In this guidance, it's only qualified by "to direct the use of the device", and "to administer the device". ...which gives the impression that there exists some kind of legal licensing program for directing/administering specific devices, which obviously there is not.

 

[somashekar]

Re: Prescription Devices - Decisions and Implications

Can you not conceive of a device that has the same procode, indications for use, technology, materials etc. as an Rx Only predicate, but which is designed in a way that overcomes the risks that previously necessitated administration by a "practitioner licensed by law"?

Lets look at it differently.
You can conceive of such a device. But you do not want a Doc to Rx it.
What will the patient / user do with your device ? Use it as and when he cares and decide that he is OK... or
Rush to the Doc at the slightest signs of reaching limits...
What your device would indicate could be the manifestation of one of several types of possible disorder.
Take the case of a finger SpO2 monitor. You get a lot of fancy type. Its cheep and a cool funky stuff with graph and such.
When I check on myself It would well show 98 - 99% SpO2 and that is normal. When I check on a aged person with an ILD, it would show about 90 - 92%. (at first you do not know that it is the case of the aged person with ILD) What would you do....
Rush to the Doc ? Provide O2 from a concentrator ? Put the patient on O2 cylinder ?
How long will you do this ? The aged person is otherwise normal and shows signs of dry cough only. You would be different when your SpO2 gets low upto 90 - 92%, and the reasons may be different. An ILD aged patient can be perfect even at 88 - 90% SpO2
The O2 concentrator would be a Rx device... you have to see a Doc to get.
The other way is the aged person is treated, diagnosed for ILD and the Doc Rx the O2 concentrator, defines the O2 level and duration, and perhaps also Rx the finger SpO2 monitor, and tells not to panic with a low SpO2 reading but take action based on symptoms, and the SpO2 levels seen in the finger monitor. The user is better informed about SpO2.
Now you are good to buy any finger SpO2 monitor in market and use on anyone in the family / friends or in the gym to see your Pulse rate as you exercise. But it comes out of Rx to a specific patient.
Could your non Rx device be in a similar situation ?
Finger SpO2 monitor is a Rx device