Class II Special Controls Guidance Document: Medical Washers and Medical...
...The test criteria should evaluate the ability of the cleaning step to remove a defined organic.....The test criteria should evaluate the ability of the cleaning step to remove a defined organic.....The test data should demonstrate that the pass/fail criteria are consistently achieved for..
http://www.fda.gov/cdrh/ode/guidance/1252.html (score=100)

stability guidance -draft
...acceptance criteria of such parameters, and the test methodology used to assess such.....Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human.....criteria for a degradant, shorter retest period, refrigerator temperature storage, or more..
http://www.fda.gov/cder/guidance/1707dft.pdf (score=98)

Do It By Design
...information necessary for establishing performance test protocols and performance criteria.....At the conclusion of the test, the actual performance times can be compared to these.....If test participants cannot safely and effectively use a device under test conditions..
http://www.fda.gov/cdrh/humfac/doit.html (score=57)

Class II Special Controls Guidance Document: Antimicrobial Susceptibility...
...FDA interpretive criteria should be used but the NCCLS criteria, if different, may also be applied if based on more current.....If you modify a suggested test method, you may cite the method but should provide.....An antimicrobial susceptibility test system is a device that incorporates concentrations..
http://www.fda.gov/cdrh/ode/631.html (score=57)

/a/content.27226
...Standardized susceptibility test procedures require the use of laboratory control.....interpreted according to the following criteria: For testing Haemophilus spp.aand.....As a false-negative result may occur in the ferricyanide test, it is recommended that..
http://www.fda.gov/cder/foi/label/2001/21222lbl.pdf (score=57)

FDA Enforcement Report For 07/22/98
...Failure to meet USP leakage test criteria. PRODUCT.. Cool Mint Listerine Antiseptic (Thymol 0..
http://www.fda.gov/bbs/topics/ENFORCE/ENF00547.html (score=57)

MDI and DPI Drug Products
...establish a set of criteria to which a drug substance or drug product should conform using.....stability test storage conditions. Additional studies should be performed to characterize.....criteria that are numerical limits, ranges or other criteria for the tests described..
http://www.fda.gov/cder/guidance/2180dft.pdf (score=20)

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...process test and the drug substance test, the acceptance criterion for the in-process test.....numeric ranges, limits, or acceptance criteria for intermediates, postsynthesis materials.....Justification for an in-process test that is used in lieu of a drug substance test should..
http://www.fda.gov/cder/guidance/3969DFT.pdf (score=18)

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...process test and the drug substance test, the acceptance criterion for the in-process test.....numeric ranges, limits, or acceptance criteria for intermediates, postsynthesis materials.....Justification for an in-process test that is used in lieu of a drug substance test should..
http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0571-gdl0001.pdf (score=18)

/a/content.30891
...criteria, and these include inappropriate test method, 18.. primarily the media.....using the criteria, what we have defined as the f2 criteria, 22.. which is a simulated.....additional arm of the test under fasting conditions. 5.. The original thought was, well..
http://www.fda.gov/ohrms/dockets/ac/00/transcripts/3657t2.pdf (score=18)

510(k) Submissions for Coagulation Instruments - Guidance for Industry and...
...and testing and should briefly describe the methods or tests used and a summary of the.....data or description of the acceptance criteria applied to address the risks identified in.....When describing your acceptance criteria or summary data, we recommend that you include..
http://www.fda.gov/cdrh/oivd/guidance/1223.pdf (score=18)

Class II Special Controls Guidance Document: Serological Reagents for the...
...If you modify a suggested test method, you may cite the method but should provide.....In developing the guidance, we carefully considered the relevant statutory criteria for.....However, failure of the test to perform as indicated or error in interpretation of results..
http://www.fda.gov/cdrh/oivd/guidance/1206.html (score=18)

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