• Publication Date: 10/01/2008
  • Author(s):
    Copley, Mark
  • Organization(s):
    Copley Scientific
  • Article Type: Technical Articles
  • Subjects: Industry Issues and Trends, Testing, Validation, and Regulatory Compliance
Exploring the implications of new regulatory guidance for testing nebulizers.

Because nebulizers historically have worked with any drug formulation designed for nebulization, regulatory agencies have had a tendency to classify them as medical devices for testing purposes. As a result, the regulatory approach has differed from that applied to other inhalation products such as DPIs and MDIs, with no requirement for drug specific testing with nebulizers. This remains, to some extent, the case in the US where regulation falls under the auspices of the Center for Devices and Radiological Health (CDRH), part of the FDA, and new devices require a 510(k) premarket notification; but regulatory authorities around the world are increasingly linking the approval of formulation and device.

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