Bringing new nebulizer technologies to market: regulatory issues.
This review outlines regulatory issues involved in bringing new nebulizer technologies to market and describes the regulatory roles of the Center for Devices and Radiologic Health and the Center for Drug Evaluation and Research. The responsible agency is determined by whether a new device involves a new drug formulation.
Meyer
Robert J
RJ
Office of Drug Evaluation, Center for Drug Evaluation and Research, United States Food and Drug Administration, Parklawn Building, 5600 Fishers Lane, Rockville MD 20857, USA.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D009330:Nebulizers and Vaporizers; D014481:United States; D014486:United States Food and Drug Administration