MDI and DPI Drug Products
...DPIs, the formulation, and the device with all of its parts including any protective.....distribution, crystallinity, dose content uniformity, microbial content, and stability.....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)

Guidance for Industry: Industry-Supported Scientific and Educational Activities
...restricted device to be misbranded. FDA's guidance on industry- drug or device is deemed.....that the company and provider agree to, the ultimate content of presentations is.....of a drug or device while it is held for sale after.. umbrella of an overall regulatory..
http://www.fda.gov/cber/gdlns/sciedu.pdf (score=97)

Class II Special Controls Guidance Document: Medical Washers and Medical...
...Guidance for the Content of Premarket Submission for Software Contained in Medical Devices.....A medical washer or washer-disinfector is a medical device intended to process medical.....Include efficacy testing as recommended in the "Content and Format of Premarket..
http://www.fda.gov/cdrh/ode/guidance/1252.html (score=97)

...the decision making tree Suggested Content for Original IDE February 27, 1996 Do Do.....Questions and Answers January 1, 1985 Do Do from FDA, from Medical Device and Diagnostic.....0 Guidance for the Preparation and December 4, 1987 Do Do Content of Applications to the..
http://www.fda.gov/cber/gdlns/guidelst.txt (score=96)

FR Doc 04-15660
...Stigi, Center for Devices and Under the Medical Device User Fee and Modernization Act of.....Content of Premarket Submissions for Center for Do Biologics Evaluation and Research.....Doyle Gantt, Center for Devices and Investigational Device Exemption Application and a..
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-15660.htm (score=95)

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