MDI and DPI Drug Products
...DPIs, the formulation, and the device with all of its parts including any protective.....recommended for inclusion in the application regarding the components, manufacturing.....stability test storage conditions. Additional studies should be performed to characterize..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...Appropriate acceptance criteria and validated test methods should be established for each.....Current designs include pre-metered and device-metered DPIs, both of which can be driven.....Furthermore, modification or alteration of these products due to changes in components of..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=36)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...A complete description of the source and composition of all device components should be provided.....Appropriate acceptance criteria and validated test methods should be established for each.....Additionally, dimensional measurements of the critical components of the device should be held to very tight..
http://www.fda.gov/cder/guidance/2180dft.htm (score=36)

...The preamble to that final rule stated that blood products that are device components or device.....There are occasions when human blood or blood components that test repeatedly reactive when screened for.....Violations of part 606 involving such device components or raw materials are subject to..
http://www.fda.gov/cber/rules/tstcomdis.txt (score=36)

Federal Register: Requirements for Testing Human Blood Donors for Evidence...
...manufacture of certain medical devices, samples of blood, blood components, infectious.....However, until such time, if the blood or blood components test.. proposed regulations will.....or as a component of a medical device, labeling shall include the statement.. the..
http://www.fda.gov/cber/rules/tstcomdis.pdf (score=36)

Microsoft Word - 916-MO~1.DOC
...Weight changes of device components should be made if the test samples are small enough.....A measure of the loads applied to the device to assemble and disassemble components may.....possible test methods, rationale/purpose of each test, pass/fail criteria or typical results for each test, literature citations..
http://www.fda.gov/cdrh/ode/916.pdf (score=31)

IVD Manual Appendixes
...All device quality control components which contribute to evaluation of testing should be clearly identified and.....Thus, this section should indicate the significance of the test results in light of the test's intended use and provide.....These are device components which can complement or augment external quality control..
http://www.fda.gov/cdrh/manual/ivdapp.html (score=31)

Process Validation
...control measures shall be established to assure that the design basis for the device, components.....The test conditions for these runs should encompass upper and lower processing limits and.....Finished product and in-process test data can be of value in process validation..
http://www.fda.gov/cder/guidance/pv.htm (score=31)

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