The Ellipta inhaler is considered to be a combination product in the same sense that a pre-filled syringe is. The Ellipta inhaler contains a drug that is combined with a device to facilitate the drug’s delivery, regardless of whether the device is packaged separately from the active drug. This would classify as a Class I 510(k) exempt device that would register with an NDA under CDER. The Ellipta inhaler uses a dry powder for the administration of inhaled medication aimed at treating asthma and COPD, therefore the primary mode of action would be a metabolic reaction, thereby classifying the product as a drug. The FDA branch that the Ellipta inhaler falls under doesn’t really come into question, but rather the classification of the inhaler itself in that although it is an everyday item that is easy to use (such as a band-aid, a tongue depressor, or another Class I product), the active drug directly affects the user’s respiratory system. This indicates that any defect in the product’s manufacturing can result in grave adverse effects, such as processing the inhaler with a drug concentration that is either too high or too low, or it may just have a defective trigger.

The medical device classification system in the U.S. has been considered to be somewhat outdated in the sense that the more medical devices being commercialized, the more broad these devices are in terms of their classification. The EU for example diverged their Class II devices into Class IIa & IIb. Both IIa and IIb devices carry medium risk and are classified under special controls, meaning that a IIa device can be held at slightly higher standards than a U.S. Class I device by methods such as implementing additional labeling requirements, more rigorous performance testing, post-market surveillance, or anything that further validates the inhaler as a medical device. Does this imply that the U.S. needs to alter its classification standards in response to the growing market for medical devices? Have there ever been any projects that folded as a result of the FDA informing the project company that their product is actually a higher classification than the company expected?

Grant, Andrew C et al. “The ELLIPTA® Dry Powder Inhaler: Design, Functionality, In Vitro Dosing Performance and Critical Task Compliance by Patients and Caregivers” Journal of aerosol medicine and pulmonary drug delivery vol. 28,6 (2015): 474-85.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=874.5220