Request Copyright Permission

US Regulatory Considerations for Inhalation Device Design

Arora Lakhani D, Coursey D.

RDD Asia 2016. Volume , 2016: 131-132.

Abstract:

In the United States, most inhalation products are considered drug–device combination products. While the primary Food and Drug Administration (FDA) center responsible for their review and approval is the Center for Drug Evaluation and Research (CDER) because the primary mode of action is the drug, aspects regarding the device may now also be reviewed by FDA Center for Devices and Radiological Health (CDRH) using the FDA’s inter-center consultative/collaborative review process. Devices that are not integrated with the drug formulation, e.g., non-drug specific nebulizers are reviewed via the “510k application” through CDRH.

The requirements set forth by the regulatory agencies play an essential role in guiding device design and are constantly evolving. The key elements of the United States regulatory framework for inhalation devices will be addressed in this presentation.