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=100)

109 Premarket Notification [510(k)] Submissions for Testing for Skin...
...The diagnostic test determining the sensitivity level of the test subjects should be.....test subject selection, scoring criteria, test results, and interpretation of results. In order to qualify for the claim.....test subject selection, scoring criteria, test results, and interpretation of results. The sensitivity level score for..
http://www.fda.gov/cdrh/ode/944.html (score=52)

Presentaion: FDA's CLIA Complexity Process
...Categorization applies to all laboratory test systems on materials derived from the human.....Waiver via CMS/PHS 1995 Criteria.. Test cleared or approved to apply for waiver through.....Clarified statutory criteria for obtaining waiver.. Guidelines list the criteria.. Final..
http://www.fda.gov/cdrh/clia/clia042302.html (score=37)

Microsoft Word - 355-CE~1.DOC
...suggests some important evaluation criteria, test procedures, and end points that FDA feels are.....these bounds to be determined substantially equivalent if the mechanical test results are.....A description of the critical manufacturing methods, QC tests and pass/fail criteria must..
http://www.fda.gov/cdrh/ode/355.pdf (score=36)

Timothy P. Mar, M.D. Warning Letter
...However, you did not in fact perform the [redacted] inclusion criteria test on the subjects prior..
http://www.fda.gov/foi/warning_letters/g4883d.htm (score=36)

57 FINAL SOFTWARE GUIDANCE COPY 2
...a software functional test plan with pass/fail criteria, data, and an analysis of the.....Unit, integration and system level test protocols including pass/fail criteria, test.....If specifications, design documentation, test plans and procedures are written for the..
http://www.fda.gov/cdrh/ode/57.html (score=36)

Microsoft Word - 916-MO~1.DOC
...Therefore, it suggests some important evaluation criteria, test procedures, and end points that FDA.....possible test methods, rationale/purpose of each test, pass/fail criteria or typical results for each test.....Corrosion test specimens should be electrically insulated from the test apparatus to avoid..
http://www.fda.gov/cdrh/ode/916.pdf (score=22)

Microsoft Word - 827--P~1.DOC
...Numerous test reports describing the physical characteristics and mechanical performance.....evaluation criteria, test procedures and end points. There may be circumstances where an.....following recommended test methods may have to be modified and/or additional methods may..
http://www.fda.gov/cdrh/ode/827.pdf (score=22)

...The source, analytical procedures, and test results for the starting materials should be.....In setting subsequent acceptance criteria, relevant correlations should be established.....This test should be performed at the lowest specified concentration of antimicrobial..
http://www.fda.gov/cder/guidance/3619fnl.doc (score=21)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...A full description of the acceptance criteria and the test methods used to ensure the identity, assay.....Appropriate, validated test methods and corresponding acceptance criteria that are reflective of the test results for.....Appropriate acceptance criteria and validated test methods should be established for each..
http://www.fda.gov/CDER/GUIDANCE/2180dft.htm (score=21)

Guidance for the Content of Premarket Submissions for Software Contained in...
...Unit, integration and system level test protocols, including pass/fail criteria, test report.....The documentation submitted should include system or device level test pass/fail criteria and a summary.....We recommend that you submit your test plans, pass/fail criteria, and summary results..
http://www.fda.gov/cdrh/ode/guidance/337.html (score=21)

Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products...
...A full description of the acceptance criteria and the test methods used to ensure the identity, assay.....Appropriate, validated test methods and corresponding acceptance criteria that are reflective of the test results for.....Appropriate acceptance criteria and validated test methods should be established for each..
http://www.fda.gov/cder/guidance/2180dft.htm (score=21)

þÿ
...The following test parameters are recommended for nasal spray drug products.Appropriate.....The stability test parameters, with appropriate acceptance criteria, should..include those test parameters identified in the drug.....Appropriate, validated test procedures and corresponding acceptance criteria that..are reflective of the test results for submitted..
http://www.fda.gov/cder/guidance/4234fnl.pdf (score=21)

þÿ
...assure that the test sample is representative of the entire batch is provided in.....production or produces additional impurities, appropriate tests, acceptance criteria.....If a stabilizer is added, test for the assay of stabilizer should be included in the..
http://www.fda.gov/cder/guidance/cmcsample.pdf (score=21)

software guidance
...If specifications, design documentation, test plans and procedures are written for the.....concern determinations have already been made for specific devices and review criteria are.....a software functional test plan with pass/fail criteria, data, and an analysis of the..
http://www.fda.gov/cdrh/ode/software.pdf (score=21)

/a//content.26262
...investigational sites, study period, patient selection criteria, and success/failure.....In general, CDRH requires that all preclinical test data must be provided before an IDE.....most devices, it may be appropriate to conduct a USP rabbit test on a saline extract of..
http://www.fda.gov/cdrh/ode/233.pdf (score=21)

software guidance
...If specifications, design documentation, test plans and procedures are written for the.....concern determinations have already been made for specific devices and review criteria are.....a software functional test plan with pass/fail criteria, data, and an analysis of the..
http://www.fda.gov/cdrh/ode/dtswguid.html (score=21)

CBER - Blood Action Plan
...criteria, test requirements and reentry. Where feasible, FDA will issue guidance to eliminate..
http://www.fda.gov/cber/blood/bap.htm (score=21)

Guidance for Reviewers - Instructions and Template for Chemistry,...
...indicating assays, which may be different from final product release criteria test methods, for.....Tabulation of Final Product Release Criteria Tests, Test Methods, Specification, Test.....Acceptance criteria are the numerical limits, ranges, or other criteria for the tests..
http://www.fda.gov/cber/gdlns/cmcsomcell.pdf (score=21)

Microsoft Word - 3619fnl.doc
...procedures, acceptance criteria, test time points for each of the tests, storage conditions,and the.....submitted that includes a list of the tests, analytical procedures, acceptance criteria.....The analytical results for each test should be reported.Representative chromatograms..
http://www.fda.gov/cder/guidance/3619fnl.pdf (score=21)

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