Update 2003: FDA and CLIA

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IVD Roundtable 510(k) Workshop April 22, 2003. Update 2003: FDA and CLIA. Clara A. Sliva, MT(ASCP), MPA Acting CLIA Coordinator FDA. Surviving CLIA. CLIA Overview --Something OLD --Something NEW Key Features Who are the players FDA and CLIA CLIA regulations - PowerPoint PPT Presentation


  • Update 2003: FDA and CLIA Clara A. Sliva, MT(ASCP), MPAActing CLIA CoordinatorFDAIVD Roundtable 510(k) WorkshopApril 22, 2003

  • Surviving CLIACLIA Overview --Something OLD --Something NEWKey FeaturesWho are the playersFDA and CLIA CLIA regulationsWhat is categorizationWhat requires categorizationWhat is not regulated under CLIA

  • Surviving CLIAHow FDA categorizes tests -CDRH -CBERAutomatic categorizationsSpecific requests for categorizationsCategorization letter; CLIA websiteWhere do you go for help

  • What is CLIA?Clinical Laboratory Improvement Amendments of 1988 (CLIA)Enacted as result of reports of inaccurate test results from Pap smearsQuestions were raised about how labs functioned and what quality control procedures existed

  • CLIA 88CLIA88 - President Reagan- 10/31/1988Social Security ActLabs receiving Medicare funds must be CLIA-certified. All clinical labs must be CLIA-certified to test human specimens Notice Proposed Rule 1990/60,000 commentsFinal Rule 2/28/1992Final QC Rule 1/24/03

  • Highlights Final QC RuleRemoves FDAs review of manufacturers' QC instructions for compliance with CLIA Sets QC standards for nonwaived testing. Reduces QC frequency in most of the subspecialtiesMerges moderate & high complexity QC requirements Uses plain language

  • Highlights Reorganizes to mimic the flow of a specimen through the lab. Studies show most lab errors are pre-analyticalRequires mod. complexity labs to validate a test once before useEnsures the test works accurately before pts. tested. Onus on laboratoryCMS drafting inspector guidelines

  • Who are the Players?Centers for Medicare and Medicaid Services (formerly HCFA) oversees CLIA Authority for regulation and policyCLIA self-funded User fees from regulated labsCMS pays FDA to categorize commercially marketed tests CDC categorizes lab procedures -Provider performed microscopy -Gram stain

  • CMS ReimbursementCLIA certificateHIPAA Privacy ActCLIA regulations, lab sends report to authorized person CLIA defines as individual authorized under State law to order tests or receive test results, or both.HIPAA-- patient requests their records from a lab, results should be sent to them.

  • CMS CLIA ContactKathy Todd, CMS ktodd@cms.hhs.govPhone: 410.786.3385 Fax: 410.786.1224

  • OIVDs CLIA PlayersRenita Hoard, CSODr. Joe Hackett, founding fatherDon St. Pierre, Deputy DirectorDr. Steve Gutman, Director CLIA team represents OIVDCBER devices ClaraCBER waiver tests- Clara, lead reviewer, OIVD CLIA team

  • Key FeaturesStandards based on complexity of testing, not the laboratory siteThe key to understanding categorization; -the analyst/operator -how complex it is for the analyst to run the test

  • FDA and CLIA1992 CLIA regulationsFDA responsible for complexity categorization1993-94 FDA categorized >900 tests1994 CDC delegated responsibilityResources, funding issues

  • FDA and CLIAImpetus for changeManufacturersCongressConfusion and duplication of effortCDC, CMS, FDA consensusInteragency agreement 2/27/99Tri-agency team CMS, CDC, FDA

  • What Regulations Govern Categorization42 CFR 493.17, categorization of specific laboratory tests by level of complexityModerate, high7 Criteria

  • Moderate, High42 CFR 493.17KnowledgeTraining and experienceCharacteristics of operational StepsCalibration, QC, PT materialsTroubleshooting, MaintenanceInterpretation and judgment

  • Moderate, High42 CFR 493.177 criteria scored as 1, 2, or 3Score of 1 = minimum Score of 3 = specializedTotal scores of 12 or less = moderate13 or higher = high e.g. PCR = high complexity

  • Categorization Regulations42 CFR 493.15 (c) Lists the 9 generic test groups Categorized by regulationAutomatically waived But still requires categorization notification letter from FDARequires posting categorization on website

  • Generic 9

    493.15 (c)dipstick and tablet reagent urinalysisfecal occult bloodovulation testsurine pregnancy testserythrocyte sedimentation ratehemoglobin (copper sulfate)blood glucose devices (FDA-cleared for OTC use)spun microhematocrithemoglobin single analyte instruments (1993)

  • Most Common Waived TestsUrine pregnancy 34%All other tests 20%Blood glucose (OTC) 18%Urine dipstick/tablet chemistries-19%Ovulation tests 5%Fecal occult blood 4%

  • Categorization RegulationsCMS and PHS Sept 13, 1995 Notice of Proposed RulemakingClarified statutory criteria for obtaining waiver Guidelines list the criteriaFinal rule pendingCMS leads tri-agency team

  • CMS/PHS Waiver CriteriaDefined simplicity, low riskDefined accuracy as comparison to reference materials, methodsPrecision field studies in hands of lay userFlex studies, different environmentsStudies distinct from FDA premarket review

  • Categorization RegulationsFood and Drug Modernization Act Nov. 21, 1997clarifies tests cleared for over-the-counter are automatically waived.But still requires categorization notification letter from FDARequires posting categorization on website

  • OTCGrowing number of OTC tests -drugs of abuse -cholesterol, HDL chol -vaginal ph -microalbumin -FSH, qual. -HgbA1C -fern test, saliva. -semen, male fertility

  • Prescription Home UsePrescription home use is an Rx device physician instructs patient to use in home FDA devices are OTC or RxAny device used in the home that is not OTCExamples prothrombin time, hemoglobin A1c

  • What is Categorization?Process of assigning new commercially marketed tests to one of 3 CLIA categories: waived, moderate, highThe key to understanding categorization; the analyst/operator and the complexity of testingRegulations that govern categorization

  • What Requires CategorizationCategorization applies to all laboratory test systems on materials derived from the human body conducted for the purpose of diagnosis, prevention or treatment, or assessment of the health

  • What Requires CategorizationPlain Language Commercially marketed test systems that produce a resultThis includes 510(k) exempt tests

  • Not CategorizedProduce no test resultQuality ControlCalibratorsTest tubesCollection kits --drugs of abuse --Hepatitis C, HIV

  • Not Categorized Not currently regulated under CLIANon-invasive (laser hematocrit)Breath tests (h. pylori, alcohol)Drugs of abuse WorkplaceMonitoring devices (Minimed)

  • How FDA CategorizesCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research

  • CDRH CategorizesPre-amendment 510(k) exempt testsNew Premarket Notification 510(k) e.g. special 510(k)sNew Premarket Approvals (original, supplements)

  • CDRH CategorizesNew Humanitarian Device Exemptions (original, supplement)510(k) add-to-files -Replacement reagents -Manufacturer name change -Relabel Previously uncategorized test systems

  • Automatic CategorizationsManufacturer submits premarket submission to Document Mail Center Categorization performed in conjunction with product reviewCLIA notification accompanies clearance, approval order or follows shortly after

  • Automatic Categorization, Replacement ReagentsWell characterized lab analyzers for use by laboratory professionals.Previously cleared instruments and reagents, when a claim is made for a new reagent/instrument combination.Introduction of new instrument family members of a previously cleared instrument family.

  • Automatic CategorizationReplacement reagentReplacement reagents require a package insert with the new instrument/reagent combinationCLIA notification follows shortly after

  • Categorization by RequestChange in company nameAdditional trade nameModification?Not previously categorized -defaults to high complexity

  • Categorization by RequestSubmit new labeling to FDADocument Mail Center, HFZ-401, 9200 Corporate Blvd., Rockville, MD 20850For CLIA Categorization OnlyReference original 510(k) numberCLIA categorization performedNotification letter to manufacturerCategorization posted on website

  • Categorization by RequestExempt from 510(k), CLIA requiredSubmit new labeling to FDAs DMCFor CLIA Categorization Only OIVD assigns X document number

  • Categorization by RequestX number accessible through CLIA databaseCLIA categorization performedCLIA letter issued Categorization posted on CLIA website

  • Categorization by RequestWaiver via CMS/PHS 1995 CriteriaTest cleared or approved to apply for waiver through processFDA approves waiver protocol Waiver studies beginTimeframe depends on queue

  • CBER:Manufacturer submits request for product review to CBERWhen test is cleared, approved, licensed CBER sends test instructions to Clara SlivaCBER test logged into CDRH CLIA database using CBER document number: BK, BP, BLA, PL

  • Rapid HIV WaiverManufacturer submits waiver application to CDRHCBER reviewer consultsCMS consultsCDRH issues letter CDRH posts categorization on CLIA website

  • Categorization Notification LetterFDAs document number is the keyk001111 new 510(k) CDRHBLA002222 new BLA CBERk001111/A1 new trade name complexitytest system name analyte name

  • Categorization Notification LetterCall dont be shyNo letter 3 weeks after clearanceIncorrect letterWebsite updates monthly

  • FDAs CLIA Workload 10/1//02 4/18/031,125 categorized912 - moderate 87 - high126 - waived

  • >1,125 Tests Categorized

  • FDAs CLIA Websitehttp://www.fda.gov/cdrh/clia/Government Google for current CLIA informationLists all waived analytes and testsLinks to CMS, CDC websitesCLIA database