Classification of Actuators for MDIs in Class 1 Medical Devices?

Hello,
I've been looking for some guidance into this question for a while now and I haven't found any insight. Perhaps you can help?

My question involves the actuator device on Metered Dose Inhalers (MDI).
The canister is of course the drug, and the valve is what regulates the metered dose.
My question is that actual actuator (the piece of plastic that the canister sits in).
My company is trying to design actuators and are unsure what areas of the regulations apply to us.

The market would be US and eventually EU.

I'm trying to find guidelines on what kind of device the actuator actually is. From my research on the FDA site, I see that only particle size testing is mentioned.
Does anyone have any experience in the MDI arena who could provide me with a bit of info?

Much appreciated.

Re: Actuators for MDIs Class 1 Medical Devices?

As far as I know, MDIs are not considered medical devices, nor is the actuator itself a device. The MDI is simply a delivery system for a drug.

Are you marketing the MDI's to drug manufacturers who will then sell the product? Or is your company the drug into the MDI and selling the finished product?

Re: Actuators for MDIs Class 1 Medical Devices?

Jean is right. The whole MDI is seen as a medicament or combination product not a medical device as such (in the US and EU). However, when I worked in this area this situation became a little muddled. The reason being that we had to supply spare actuators to doctors etc who requested them (i.e. minus the canister). Under these circumstances I thought it wise to self certify them as separate Class I medical devices i.e. put a CE mark on them (and register with the MHRA in the UK). I then produced a separate Technical File i.e. treating them as stand alone items, even though their details etc were in the Drug Master File for the particular drug that they dispensed.

But see below with respect to the definition of ‘combination products’.

https://www.fda.gov/CombinationProd...formation/JurisdictionalUpdates/ucm103179.htm

I don’t know if this input helps or confuses matters.

Steve

Re: Actuators for MDIs Class 1 Medical Devices?

Thank you!
Both responses helped tremendously!
In answer to one of the questions, the company will not manufacture drug product.
It seems then that this would be a class I medical device (The actuator only) that would be exempt from 501k filing?

Re: Actuators for MDIs Class 1 Medical Devices?

or rather..nothing at all since your are saying it's not a medical device!
Sorry, I missed that one part!

Re: Actuators for MDIs Class 1 Medical Devices?

I think I have to backtrack now and I apologize for not having seen this earlier. I did not look closely enough.

FDA regards all nebulizers and MDI's as prescription devices. The device manufacturer must have a cleared 510(k) premarket notification before marketing the device.

Click to expand...

https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081282.htm

Type "metered does inhaler" into the searchbox.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm

It looks like the product code is CAF and the device is Class II requiring clearance.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=84

Sorry to give you misleading information earlier!

Re: Actuators for MDIs Class 1 Medical Devices?

That's why I came here because the only thing I could find on the FDA site was something for the metered dose inhalers.

I see nothing that separates the two. A metered dose inhaler contains a canister AND an actuator.
I'm only interested in the actuator part.

Of course the FDA has an email address to get answers from on medical devices, and I've emailed him twice with no response.

So was hoping to use the internets because there have to be some people out there who work in the MDI industry. (I'm biologics myself. As me about a pre-filled syringe...no issues with that!)

Re: Actuators for MDIs Class 1 Medical Devices?

OK let me try again.

Are you manufacturing the actuator for a customer who then manufactures the MDI? If so then your customer will have to file and you are a supplier.

It can take a LONG time to get a response from the FDA. Try calling, sometimes you get lucky and get someone right away.

Hello.

Legal requirements for the US are in the FDA's QSR part 820.

All the legal requirements for the EU are laid out in 93/42/EEC.


How you fulfill these requirements is up to your organisation.

You might want to implement standards to do this.
If so, then all you need are 13485, 14971 & 980.

To compliment what Jean has said.

When I did work in the pharmaceutica industry on MDIs, the status was that the supplier of the actuators did just that – supply them to specification etc (drawing, spray pattern, stem fit, impactor particle size distribution etc). They did not have to put together a technical file (under the MDD 93/42/EEC) or be ISO 13485 (or EN 46001 as was) certified. The regulatory responsibility was all down to the company (us) that supplied the drug and put the whole package together. The same applied to the suppliers of the canister/valve - they were just component suppliers. All suppliers ideally were ISO 9001 certified but that was about it. As indicated previously, I took the responsibility (for the pharmaceutical company) for registering the actuator as a medical device under the option of it being supplied to the market as a stand alone entity. As a supplier of actuators to the pharmaceutical company I do not think you have to do anything other than submit to auditing (ISO 9001, GMP or their bespoke format) by the pharmaceutical company that you supply.

Steve