FDA Product Code CAF: Nebulizer (direct Patient Interface)

Nebulizers convert liquid medication into an inhalable aerosol. FDA product code CAF covers nebulizers with direct patient interface used for respiratory drug delivery.

These devices use compressed air, ultrasonic vibration, or vibrating mesh technology to aerosolize bronchodilators, corticosteroids, and other respiratory medications into particles small enough to reach the lower airways. They are used in the treatment of asthma, COPD, and cystic fibrosis.

CAF devices are Class II medical devices, regulated under 21 CFR 868.5630 and reviewed by the FDA Anesthesiology panel.

Leading manufacturers include Adherium (Nz), Ltd., C.R. Bard, Inc. and Trudell Medical International.