MDI and DPI Drug Products
...manufacturing, processing, packaging, controls, stability testing, or labeling operations.....For MDI and DPI drug products, certain studies should be performed to determine.....DPIs, the formulation, and the device with all of its parts including any protective..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA)...
...The appropriateness of conducting accelerated stability studies is related to device composition and the relationship.....Stability studies should monitor the critical physical and mechanical properties of a device that.....After FDA determines that the device is substantially equivalent, clinical studies conducted in accordance with the indications..
http://www.fda.gov/cdrh/ode/guidance/668.html (score=91)

510(k) Submissions for Coagulation Instruments - Guidance for Industry and...
...system for in vitro coagulation studies is a device cons isting of one automated or semi-automated.....Protocol and acceptance criteria for real-time or accelerated stability studies .. for.....demonstrating substantial equivalence for a new device, particularly once FDA has issued a..
http://www.fda.gov/cdrh/oivd/guidance/1223.pdf (score=66)

Assisted Reproduction Laser Systems - Class II Special Controls Guidance...
...6Refer to Significant Risk and Nonsignificant Risk Medical Device Studies in Guidance for.....We recommend that you assess the device’s aiming stability and describe the: target designation procedure.....While, in general, clinical studies will not be needed for most assisted reproduction..
http://www.fda.gov/cdrh/ode/guidance/1539.html (score=45)

...Nucleic Acid Characterization and Genetic Stability Draft PTC in the Characterization of.....Questions and Answers January 1, 1985 Do Do from FDA, from Medical Device and Diagnostic.....Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived..
http://www.fda.gov/cber/gdlns/guidelst.txt (score=43)

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