20xx資料-7--臨床評(píng)價(jià)報(bào)告模板2(編輯修改稿)
2025-01-17 02:57 本頁(yè)面
【文章內(nèi)容簡(jiǎn)介】 接觸的器官，組織或體液。
描述器械如何達(dá)到它的預(yù)期用途。
3. Intended therapeutic and/or diagnostic indications and claims預(yù)期治療和/或
診斷說(shuō)明和要求
State the medical conditions to be treated, including target treatment group and diseases.
Outline any specific safety or performance claims made for the device
描述使用時(shí)的醫(yī)學(xué)條件，包括目標(biāo)治療群體和疾病。概述器械的任何特殊安全或性能要求。
4. Context of the evaluation and choice of clinical data types評(píng)估背景和臨床數(shù)
據(jù)類型的選擇
Outline the developmental context for the device. The information should include whether the device is based on a new technology, a new clinical application of an existing technology, or the result of
incremental change of an existing technology. The amount of information will differ according to the history of the technology. Where a pletely new technology has been developed, this section would
need to give an overview of the developmental process and the points in the development cycle at which clinical data have been generated. For long standing technology, a shorter description of the history of the technology (with appropriate references) could be used. Clearly state if the clinical data used in the evaluation are for an equivalent device. Identify the equivalent device(s) and provide a justification of the equivalency, crossreferenced to the relevant nonclinical documentation that supports the claim.
概述器械的發(fā)展歷史。內(nèi)容應(yīng)包括器械是否基于新技術(shù)，是否基于現(xiàn)有技術(shù)的新臨床應(yīng)用，或者是現(xiàn)有技術(shù)增量變化的結(jié)果。根據(jù)該技術(shù)的歷史，信息量將有所不同。如果是一項(xiàng)全新技術(shù)發(fā)展起來(lái)，本章須概述發(fā)展過(guò)程和發(fā)展周期中產(chǎn)生臨床數(shù)據(jù)的節(jié)點(diǎn)。如果是常規(guī)技術(shù)，須簡(jiǎn)短描述該技術(shù)的歷史（須適當(dāng)引用）。明確指出，評(píng)估中使用的臨床數(shù)據(jù)是否來(lái)自等同器械。識(shí)別等同器械，并給出等同的理由，參照相關(guān)非臨床文獻(xiàn)，以支撐觀點(diǎn)。
State the Essential Requirements relevant to the device in question, in particular, any special design features that pose special performance or safety
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