The Investigational Device Exemptions (IDE) regulation (21 CFR 812) describes three types of device studies: significant risk (SR), nonsignificant risk (NSR), and exempt studies.

2023年9月27日 · The FDA has the ultimate decision in determining if a device is SR or NSR. On some occasions, FDA may overrule the IRB's decision that a device presents NSR or SR.

FDA has the ultimate decision in determining if a device study is SR or NSR. If the Agency does not agree with an IRB's decision that a device study presents an NSR, an IDE application must be submitted to FDA.

Learning objectives Make distinction between significant risk (SR) and non-significant risk (NSR) device studies Describe three criteria IRBs should consider when making the SR/NSR...

The FDA has the ultimate decision in determining if a device is SR or NSR. On some occasions, the FDA may overrule the IRB's decision that a device presents NSR or SR.

研究风险确定指的是申请人要求FDA确定处于计划中的医疗器械的临床研究是否为重大风险（SR），非重大风险（NSR）或可IDE豁免。 对于非IDE豁免研究，申请人有责任进行初步风险判定（SR或NSR）并将其提交给机构审查委员会（IRB）。 FDA可帮助申请人以及临床研究者和IRB进行风险判定，并可以最终裁决临床研究是重大风险还是非重大风险。 信息会议指的是申请人可以自愿通过会议的方式与FDA分享产品研发过程中的信息，从而使FDA熟悉这个新产品。 …

FDA regulations (21 CFR 812.2) state that for studies involving use of an investigational device, the investigator (or sponsor) must obtain either a "significant risk" (SR) Investigational Device Exemption (IDE) from the FDA, or a determination of "non-significant risk" (NSR) from the institutional review board (IRB).

device studies; "significant risk" (SR) and "nonsignificant risk" (NSR). Significant risk device [21 CFR 812.3(m)] means an investigational device that: (1) is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (2) Is purported or represented to be for a use in supporting or sustain...

2023年7月14日 · 根据风险程度，分为不同管控措施：重大风险（Signifcant Risk，SR）、非重大风险（Non- Signifcant Risk，NSR）和可豁免。 伴随诊断通常不适用于IDE管控豁免。 因此，对于有伴随诊断的新药临床，在 药物IND申请时便应考虑申请判定IVD是否存在重大风险（Signifcant Risk Determination，SRD）。 如果判定属于SR，则申报方需要先将CTA验证数据和其它相关资料提交FDA，FDA批准后才能开始临床试验；如果属于NSR，也必须完成相应的性能验证和资料 …

2022年9月11日 · 食品和药物管理局（FDA 或该机构）是美国保健产品领域的监管机构，已发布了一份 指导文件 致力于重大风险 (SR) 和非重大风险 (NSR) 医疗器械研究。