FOOD AND DRUG ADMINISTRATION
...Meyer indicated in his slide, there's a package of information with the formulation/device.....That the device should be comparable, either the same device meaning the same metering valve and pump, or one made preferably by the.....formulation itself might present in terms of clinical efficacy, given everything else..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3763t1.htm (score=100)

...Meyer indicated in his slide, there's a package of information with the formulation/device.....That the device should be comparable, either the same device meaning the same metering valve and pump, or one made preferably by the.....formulation itself might present in terms of clinical efficacy, given everything else..
http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3763t1.txt (score=100)

MDI and DPI Drug Products
...DPIs, the formulation, and the device with all of its parts including any protective.....reservoir containing sufficient formulation for multiple doses which are metered by the.....an internal reservoir containing sufficient formulation for multiple doses that are..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=47)

Dental Impression Materials
...Provide the complete impression material formulation, identifying the individual chemical.....Medical device manufacturers may elect to rely upon recognized consensus standards during.....Dental Impression Material is a class II device composed of materials such as alginate or..
http://www.fda.gov/cdrh/ode/impress.html (score=32)

CDRH Medical Device Electromagnetic Compatibility Program
...Chief among the accomplishments is the formulation of strategies to address EMC in all.....In this case the solution requires the involvement of the device industry, the EM source.....Nonetheless, there are some critical device areas where the threat from EMI could directly..
http://www.fda.gov/cdrh/emc/persp.html (score=32)

Class II Special Controls Guidance Document: Medical Washers and Medical...
...Provide the formulation for the concentrate and the in-use dilution for all accessory.....A medical washer or washer-disinfector is a medical device intended to process medical.....Regulatory requirements pertaining to the marketing of a new medical device are available..
http://www.fda.gov/cdrh/ode/guidance/1252.html (score=31)

Special Control Guidance Document on Encapsulated Amalgam, Amalgam Alloy,...
...If the Encapsulated Amalgam, Amalgam Alloy, or Dental Mercury device contains a material.....formulation as a single component or in an admixture with other substances. 2.2 USE OF.....device into commercial distribution in the United States, will be able to market their..
http://www.fda.gov/cdrh/ode/guidance/1192.html (score=31)

Use of Standards in Substantial Equivalence Determinations
...formulation and biocompatibility of device materials that contact the fluid path.Manufacturers have identified metal.....a new device was similar to previously marketed devices in the areas covered by the.....Thus, information on the device's conformity with a standard could take the place of..
http://www.fda.gov/cdrh/ode/guidance/1131.pdf (score=31)

Use of Standards in Substantial Equivalence Determinations
...510(k)s for external infusion pumps typically contain information on the chemical formulation and biocompatibility of device.....Normally, if an FDA-recognized standard is applicable to a device, the device will be identified in.....Rather than always requiring data from comparative testing of the new device and a legally marketed device, ODE has..
http://www.fda.gov/cdrh/ode/guidance/1131.html (score=31)

Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA)...
...87, including the proposed labeling for the device sufficient to describe the device, its intended use, and the directions.....a new intended use or certain changes to the bone cement’s chemical formulation, including.....If the finished device does not meet the acceptance criteria, and thus differs from the..
http://www.fda.gov/cdrh/ode/guidance/668.html (score=31)

Premarket Approval Decisions for November 2001
...Approval for relocation of the formulation of the bulk past and the equipment and.....The vessels that can be treated with the device are the innominate and subclavian veins.....The device is indicated for use in patients undergoing open, conservative gynecologic..
http://www.fda.gov/cdrh/pma/pmanov01.html (score=31)

Document
...and the maximum content of tin, associated with the use of the device, in.. consensus.....variations in chemical formulation.. Devices that were not in commercial.....controls for the existing class II device, the amount of vapor released. The.. majority of..
http://www.fda.gov/OHRMS/DOCKETS/98fr/022002a.pdf (score=31)

...A preamendments device that has been classified into class III may be marketed, by means.....formulation related to percent composition and types of materials. In the Federal Register.....Due to an inadvertent error, the preamendments device encapsulated amalgam alloy and..
http://www.fda.gov/OHRMS/DOCKETS/98fr/022002a.htm (score=31)

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