Prescription Devices - Who is Responsible / Liable?

[Mark Meer]

Who is responsible for ensuring that devices designated prescription only are, in fact, used only under prescription conditions?

I'd brought this up in a previous post regarding a number of discussions surrounding implications of a device designated as prescription only in the US, but the thread kindof veered away from this particular question, so thought I'd start a new dedicated thread.

So, who is responsible? How is it checked? To what degree is it enforced?

If you are a manufacturer selling directly to an end-user, are you responsible for confirming that the device is used only "under the supervision of a practitioner licensed by law to direct the use of the device", prior to sale?
If you are selling through a distributor, is this responsibility (with distributor) typically specified in writing?
If you sell to a clinic/medical-facility, is the clinic/facility responsible?

If the device is found NOT being used "under the supervision of a practitioner licensed by law to direct the use of the device", and there is an adverse event, who is liable? (manufacturer vigilance activities aside)

...or, is the "Rx Only" designation on the label simply treated like a warning or contraindication, and it is the responsibility of the end-user to abide by (hence no additional controls/pre-sale criteria by the manufacturer are necessary)...?

 

[Pads38]

Prescription devices are restricted by 21CFR801.109.

Firstly it restricts lawful possession of such devices to licensed practitioners or lawful manufacturers/ distributors etc.

Secondly, sale of such devices is restricted to licensed practitioners or on order of such practitioner.

Then the labelling requirement of "Caution: Federal law restricts the sale..."

So I would suggest that a manufacturer (or agent) is compelled to limit sales to duly licensed persons but once in the possession of the clinic / hospital it is that organisations responsibility to limit use of the device.

 

[Mark Meer]

Prescription devices are restricted by 21CFR801.109.

Firstly it restricts lawful possession of such devices to licensed practitioners or lawful manufacturers/ distributors etc.

Secondly, sale of such devices is restricted to licensed practitioners or on order of such practitioner.

Then the labelling requirement of "Caution: Federal law restricts the sale..."

So I would suggest that a manufacturer (or agent) is compelled to limit sales to duly licensed persons but once in the possession of the clinic / hospital it is that organisations responsibility to limit use of the device.

Thanks Pads. I'm aware of the regulation and labelling requirement, I'm just not clear how this all plays out in practice...

How is vetting of "licensed practitioners" or "order of such a practitioner" carried out? What are the documentation/record-keeping requirements?

Is the seller expected to verify credentials? If so, what are the criteria? Does the practitioner have to be MD? RN? Therapist? Who/what determines the qualifications?

Or, if the seller is expected to verify the "order of such a practitioner" prior to sale, again, what are the requirements? An email? A letter? A formal prescription?... Even then, there is still the question above: is the seller responsible for verifying the (prescribing) practitioner's qualifications?

 

[Al Rosen]

The licenses required to dispense or order the use of the devices are issued by the State. You may only sell to those individuals so it is up to you to verify that those you sell to are properly licensed. You obviously must maintain the evidence that the buyer provided. I'm not suggesting this as the primary evidence, but you can even verify professional licenses on the internet.

 

[Mark Meer]

The licenses required to dispense or order the use of the devices are issued by the State. You may only sell to those individuals so it is up to you to verify that those you sell to are properly licensed. You obviously must maintain the evidence that the buyer provided.

Thanks for clarifying a bit...but still not totally clear how this works.

• Are these licenses issued state-by-state?
• Are the licenses specific to a given device pro-code, or is there just a single license? In other words, would the license be the same for a Rx personal rehabilitative therapy device as it would for a life-sustaining device?
• Can you sell directly to users who provide evidence that they are being prescribed the device by such a qualified person (e.g. in a signed recommendation letter)? If so, is it expected that the manufacturer then take additional steps to verify the identity and credentials of the prescriber?
• If a US-based distributor is responsible for sales in the US on behalf of the manufacturer, can this responsibility be designated to the distributor? Or is it always the manufacturer who is ultimately responsible?

 

[Al Rosen]

Thanks for clarifying a bit...but still not totally clear how this works.

• Are these licenses issued state-by-state?

Yes

• Are the licenses specific to a given device pro-code, or is there just a single license? In other words, would the license be the same for a Rx personal rehabilitative therapy device as it would for a life-sustaining device?

It's the same license, MD who is trained.

• Can you sell directly to users who provide evidence that they are being prescribed the device by such a qualified person (e.g. in a signed recommendation letter)? If so, is it expected that the manufacturer then take additional steps to verify the identity and credentials of the prescriber?

No, unless you have a license to Dispense.

• If a US-based distributor is responsible for sales in the US on behalf of the manufacturer, can this responsibility be designated to the distributor? Or is it always the manufacturer who is ultimately responsible?

The distributor needs to be licensed and is responsible.

 

[Mark Meer]

It's the same license, MD who is trained.

How do you determine/verify that they are trained? Or is the criteria just an MD? Is MD essential, or are there other certifications/credentials that would suffice?

Browsing the AMA's Doctor Finder, and from pulling up random profiles. Say I want to sell them Rx device X. What exactly am I looking for?

No, unless you have a license to Dispense.
...
The distributor needs to be licensed and is responsible.

What is this license? Is it specific to a given device procode or class, or just a general license to sell Rx devices directly to patients (with prescriptions)? Is it also issued state-by-state? If so, then a US distributor would have to hold 50 separate licenses?

Can you kindly link to where I can get more specific requirements about this? We may have to re-negotiate arrangements with distributors...


Much appreciate your input on this!

 

[Al Rosen]

Each state controls and licenses.

NYS Professions - Online Verifications

https://www.morganlewis.com/-/media...on-of-medical-device-distribution-update.ashx

You should ask the buyer to provide evidence that they are licensed in the state that they operate.

I also suggest you consult an attorney experienced in this area.

 

[Statistical Steven]

Think of it like lawyers. Each state sets the requirements to be considered a member of the State Bar. Device license to distribute is set at the state level. For example, my CPAP accessories are sent to me by a licensed medical distributor in the state of MD. When I lived in NJ, I had a different distributor. The NJ distributor cannot ship me my supplies in Maryland, unless they got a license in the state. Most of this is actually covered by Federal Statutes for Inter-State Commerce.

 

[Sarah Stec]

At a very high level: You can also think of it like a pharmacy (also regulated at the state level, verifies prescription-writing authority before filling the prescription, etc.). In order to dispense drugs/devices in the state, the pharmacy (the physical location) must have a pharmacy license that allows them to dispense (i.e. selling to end users/doctors). There are different pharmacy licenses for distribution (i.e. selling to pharmacies/doctors), manufacturing (i.e. the manufacturing process including the point of sale to distributors), reverse distributors, etc. Selling directly to patients upon prescription from an MD could be different from selling to doctors upon their prescription for the doctor to administer/give the product to the patient.

If you came to me with this question, I would start at the different state's pharmacy regs. Assume each state defines "dispense" and "distribute" differently, just in case.

If so, then a US distributor would have to hold 50 separate licenses?

IME, this is what happens.