As per MRFR analysis, the US Smart Inhalers Market Size was estimated at 436.1 (USD Million) in 2023. The US Smart Inhalers Market Industry is expected to grow from 488.04(USD Million) in 2024 to 1,208 (USD Million) by 2035. The US Smart Inhalers Market CAGR (growth rate) is expected to be around 8.588% during the forecast period (2025 - 2035).

There are several key regulatory agencies who oversee the approval and monitoring of Smart Inhalers to ensure their safety, efficacy, and quality.

people diagnosed with Asthma, or chronic obstructive pulmonary disease (COPD), or any other respiratory illness requiring inhaled medication, patient suffer with medication adherence, frequent hospital visits or poor control on Asthma or COPD are all ideal for administering their drugs using these smart inhalers.

Smart inhalers integrate traditional inhalation therapy with digital technologies for monitoring and improving medication adherence are subjected to regulatory oversight to ensure safety and efficacy, in US smart inhalers are regulated by food and drug administration (FDA).

Fda has classified all medical devices into…

Medical devices are classified into three categories based on evaluation of risk they can pose to the patient, including class I, II, III. Class I is of low risk and needs only general control submission, class II is of moderate risk and needs general and special controls typically need 510(k) clearence. Class III poses high risk and is strictly regulated and requires Premarket Approval (PMA). Identifying the class of the device under development is important if it is class II than premarket notification 510 (k) is required which needs evidence of substantially equivalent device already legally marketed to prove the efficacy of new product.

Under 21 CFR 3.2 (e) combination products are defined as product comprising drug/device/biologic components combined in one entity, smart inhalers integrated with digital technology or sensors fall under combination product category and needs multicentered FDA review, including divisions of FDA like center for drug evaluation and research (CDER), center for devices and radiological health (CDRH),  center for biologics evaluation and research (CBER) for meeting all compliance requirements of the product.

General use devices like nebulizers need 510 (k) pathway via CDRH. Drug specific devices like smart inhalers need device modules in NDA/ IND or a separate 510 (k) if drug is already approved.

Smart Inhalers are evaluated based on

Submit all the data collected regarding the product performance, risk analysis, standards along with the suitable regulatory submission like PMA or 510 (K) to FDA for review, if the product is meeting or complying with all the regulatory standards set by FDA it is approved and allowed to be marketed.

FDA track the product even after marketed to ensure its safety and efficacy to patient throughout the use of product and even check for any adverse event reporting if found they immediately go for product recall.