Guidance for Industry: Source Animal, Product, Preclinical and Clinical...
...from a nonhuman source, or xenotransplantation product materials used in encapsulated form.....Some products may be combination products consisting of a biologic and a device, such as.....Master Files are submitted to FDA and contain information regarding a product, such as product manufacture..
http://www.fda.gov/cber/gdlns/clinxeno.pdf (score=100)

MDI and DPI Drug Products
...An alternative approach may be used if such approach satisfies the requirements of the.....The guidance sets forth information that should be provided to ensure continuing drug.....DPIs, the formulation, and the device with all of its parts including any protective..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=96)

General Principles of Software Validation; Final Guidance for Industry and...
...Most of the automated equipment and systems used by device manufacturers are supplied by third.....Unless specifically exempted in a classification regulation, any medical device software product developed.....The device manufacturer is responsible for ensuring that the product development methodologies used by the OTS software..
http://www.fda.gov/cdrh/comp/guidance/938.html (score=82)

General Principles of Software Validation; Final Guidance for Industry and...
...Most of the automated equipment and systems used by device manufacturers are supplied by third.....Such tools should have a degree of quality no less than the software product they are used.....Unless specifically exempted in a classification regulation, any medical device software..
http://www.fda.gov/cdrh/comp/guidance/938.pdf (score=82)

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