Are Inhalers and Aerosols Medical Devices?

v9991

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#11
Jurisdictional Update: Metered Dose Inhalers, Spacers and Other Accessories

FDA has concluded that MDIs are drug – device combination products. 1 Based on the agency’s determination that the primary mode of action of MDIs is attributable to the drug component, the Center for Drug Evaluation and Research (CDER) has regulated these products under the new drug provisions of the Federal Food, Drug, and Cosmetic Act (the act). This jurisdiction document applies equally to dry powder inhalers.

Actuators are an essential part of an MDI; the drug cannot be delivered to the patient without an actuator. Actuators also play a crucial role in the delivery characteristics of MDIs. The concept of a general use actuator is not appropriate because of this link to dosing performance; an actuator significantly affects the safety and efficacy of the drug, and must always be studied with a particular MDI drug. Therefore, replacement actuators have been determined to be device components of combination products. Based on FDA’s determination that the primary mode of action of the combination product is attributable to its drug component, actuators have been regulated by CDER under the new drug provisions of the act 4

Spacers incorporating actuators are designed to replace the actuator of an approved MDI. As with replacement actuators without a spacer, the concept of a general use actuator – spacer is not appropriate because an actuator must be studied with a particular drug. Therefore, actuator – spacers have been determined to be device components of combination products. Based on FDA’s determination that the primary mode of action of the combination product is attributable to its drug component, spacer - actuators have been regulated by CDER under the new drug provisions of the act.

Dose counters or dose indicators count the number of doses administered by an MDI and display either numerically or by some other means the number of remaining doses, so that the patient will be aware when the drug canister has delivered its labeled contents. The force needed to actuate MDIs may vary from product to product by design, depending on factors such as the valve utilized in the product. For dose counters to provide accurate information, the force needed to actuate the counter must match the force needed to actuate the valve. Otherwise, "count-not-fire" and "fire-not-count" scenarios may occur. The "fire-not-count" scenario is particularly worrisome because the counter may indicate that the drug is available, when in fact the canister is empty.


Examples of combination products include: drug eluting stents, antimicrobial coated catheters, condoms with spermicide, and pre-filled drug or biologic delivery devices such as injector pens, metered dose inhaler, and transdermal patches.
July 8, 2003 - Innovative Systems for Delivery of Drugs and Biologics: Scientific, Clinical and Regulatory Challenges: Summary of FDA Workshop

also an interesting ref. on other products.,.
Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health

 
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chris1price

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#12
As always, EU rules are very similar... but not quite the same. In May 2016 MHRA released guidance on borderline products indicating which are medical devices (MDR) and which require medicinal Marketing Authorisation (MA).

It includes a very useful comparison table:

11. Inhalation products
a. Prefilled metered dose inhalers - MA
b. Chamber spacers for use with metered dose inhalers - MDR
c. Spinhalers - } refillable - MDR
d. Diskhalers - } refillable - MDR
e. Other empty or re-fillable inhalers - MDR

(b), (c), (d) & (e) may be sold with medication and their performance/drug delivery will be assessed by a drug regulatory authority as part of the medicines Marketing Authorisation application.

https://www.gov.uk/government/uploa...ective_equipment__cosmetics_and_biocides_.pdf

Chris
 

chris1price

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#14
S

SteveK

#15
To follow on from Chris’s list. I remember many years ago when I worked in the Pharma industry we supplied Metered Dose Inhalers (MDIs). These were seen purely as a medicament. However, a number of medics and others wanted the plastic component to be suppled separately e.g. as a replacement. So rather quickly we created a Technical File for this component as a medical device and had to modify the tooling such that it carried a CE mark as a Class I device. I do not know if this is still the case with MDIs currently.

Steve
 
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