FDA Assay Migration Studies for In Vitro Diagnostic Devices Guidance for Industry and FDA Staff

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Assay Migration Studies for In Vitro Diagnostic Devices Guidance for Industry and FDA Staff[附网盘链接]由FDA于过去发布，适用于United States。

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Assay Migration Studies for In Vitro

Diagnostic Devices

Guidance for Industry and FDA Staff This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. Introduction This guidance outlines FDA’ rs egulatory approach for approval of Class III in vitro 1 2 diagnostic devices, as well as certain licensed or certain cleared in vitro diagnostic devices in cases, w hen a previously approved, licensed, or cleared assay is migrating (i.e., transitioning) to another system for which assay performance has not been evaluated by 2 FDA. In this guidanewnc syste temhe” r teefretmrhe “s t systo em (assay, instrument, and software) to which trheom a assa pry ievis mousligry aactlpprieng f aroveed d/licensed/

systTehem. t e“rolm d syst” refe etmrhe systs to em (assay, instrument and software) which waas pproved/clliecaferrnsee om d wdhi/ ch the assa cury irs mentigrly ating to a unapproved/unli systcense. emd/uncleared Thi guis da nce is f ocused on tperhe forst maudy dence crsii tgns aeriand that should be fulfilled in orutdeir tl fh iore ze m ai sponsorgration st to udy a pproach in support of the cha. nge FDA will review information fesulromtnas of ttlheiyc a sponsoral and , including r

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describes ithanftor wem rateicon ommend you (priencmalrudeke t i an appr PMA oval 1 This guidance does not apply to immunohematology tests licensed by the Center for Biologics Evaluation and Research (CBER). 2 This guidance can be used for 510(k) devices where the Replacement Reagent and Instrument Family Policy (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079185.htm) does not apply (e.g., nucleic acid amplification tests) and devices for which transitioning to a new system presents specific concerns, either because of the nature of the analyte and indications, or because of the specific technology used. 1

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