MDI and DPI Drug Products
...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.....recommended for inclusion in the application regarding the components, manufacturing..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=100)

Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk...
...device components to operate in ways that are consistent with their experience with other similar.....through careful inspection and analyses of existing information pertaining to the use of.....consider the possibilities of hazards arising from failures of the device and its components.These kinds..
http://www.fda.gov/cdrh/humfac/1497.pdf (score=97)

ORA Import Program Start Page
...Information related to products subject to FDA's control of foods (except for certain.....device components, food and color additives, and dietary supplements) intended for further.....This link offers access to the OASIS Information Sections. These pages contain guidance..
http://www.fda.gov/ora/import/ora_import_program.html (score=77)

904 ELECTROSURGICAL DEVICE GUIDANCE -G1O
...new device, significant modification of device previously found equivalent, new intended use, new material, or different.....You must also supply adequate information, which may be the same information needed for a.....All purchased drug or biologic components are also packaged and labeled consistent with..
http://www.fda.gov/cdrh/ode/904.html (score=53)

Testimony of William K. Hubbard on Medical Device Year 2000-APRIL 15, 1999
...FDA has taken a number of constructive actions to work with manufacturers and provide information to users about medical.....products containing embedded microchips which are part, or components, of the devices.....Once information on compliant products is received from medical device manufacturers it..
http://www.fda.gov/ola/1999/meddev415.html (score=32)

The Least Burdensome Provisions of the FDA Modernization Act of 1997:...
...This concept applies to all devices and device components of combination products regulated by.....Whenever possible, FDA and industry decisions about device development and review should rely on information that is available from.....Having stated the above, it is important to note that while information about a device..
http://www.fda.gov/cdrh/ode/guidance/1332.html (score=32)

TESTIMONY OF THOMAS SHOPE, PH.D., (APRIL 20, 1999)
...FDA has taken a number of constructive actions to work with manufacturers and provide information to users about medical.....products containing embedded microchips which are part, or components, of the devices.....Once information on compliant products is received from medical device manufacturers it..
http://www.fda.gov/ola/1999/meddev420.html (score=32)

TESTIMONY WILLIAM K. HUBBARD (MAY 25, 1999)
...FDA has taken a number of constructive actions to work with manufacturers and provide information to users about medical.....products containing embedded microchips which are part, or components, of the devices.....Once information on compliant products is received from medical device manufacturers it..
http://www.fda.gov/ola/1999/meddevy2k.html (score=32)

Guidance for Industry and FDA Staff: Class II Special Controls Guidance...
...For additional information regarding device manufacturing records, the manufacturer should.....Qualification of Other Components ..The source and purity of all other components and.....and other agency information on this topic, such as CDRH's Device Advice on the Internet..
http://www.fda.gov/cber/gdlns/humduramat.pdf (score=32)

Guidance for Industry and FDA Staff: Class II Special Controls Guidance...
...For additional information regarding device manufacturing records, the manufacturer should refer to 21 CFR 820.....FDA Revised Recommendations to Blood Establishments for “Testing Whole Blood, Blood.....Because product classification was not finalized and new information about the safety of this device became available during..
http://www.fda.gov/cber/gdlns/humduramat.htm (score=32)

P000008b.doc
...fabricate the device, components from which the device is assembled, the finished device.....After review of the additional information, CDRH determined that there is sufficient.....device's packaging, sterilization process of the device, and product shelf life..
http://www.fda.gov/cdrh/pdf/P000008b.pdf (score=32)

...FDA has amended the identification of the device to clarify that not all of the described.....However, FDA considers this information along with the information provided in other.....Classification and reclassification of the device from class III to class II when the device is intended to provide immobilization..
http://www.fda.gov/ohrms/dockets/98fr/072798b.txt (score=31)

IVD Manual Appendixes
...If you wish to pursue the marketing of this device and need information or assistance for preparing PMA.....All device quality control components which contribute to evaluation of testing should be clearly identified and.....If the QC material is included as a part of the device under review, performance information and labeling should follow..
http://www.fda.gov/cdrh/manual/ivdapp.html (score=31)

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