MDI and DPI Drug Products
...DPIs, the formulation, and the device with all of its parts including any protective.....also known as oral and nasal metered dose inhalers respectively or MDIs) and inhalation.....designs include pre-metered and device-metered DPIs, both of which can be driven by..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

CDRH Fiscal Year 2000 Annual Report
...expertise in the particular device area, identify the issues related to the device, the.....fraction of the radiation dose common in medical diagnostic procedures, but has a.....calculated an average annual solar UV dose based on data from the Environmental Protection..
http://www.fda.gov/cdrh/annual/fy2000/annualreport-2000.pdf (score=84)

Document
...and the maximum content of tin, associated with the use of the device, in.. consensus.....1) No systemic dose- study, drawn from approximately 1,200.. rare instances, cause local.....controls for the existing class II device, the amount of vapor released. The.. majority of..
http://www.fda.gov/OHRMS/DOCKETS/98fr/022002a.pdf (score=82)

...There is no valid scientific evidence demonstrating specific adverse responses or a dose.....A preamendments device that has been classified into class III may be marketed, by means.....Due to an inadvertent error, the preamendments device encapsulated amalgam alloy and..
http://www.fda.gov/OHRMS/DOCKETS/98fr/022002a.htm (score=82)

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