Home 醫材法規 【美國醫材】FDA調降放射醫材等級:醫學影像分析類


by 愛姆斯

FDA上周發佈一份規則將部份放射醫學影像分析的醫材像是用於乳癌,檢查的乳房X光電腦輔助診斷產品(computer-assisted detection, CADe) 重新分類,從第III級降為第II級此法規將,

  • 重新分級部份CADe產品,從III降為II級,未來可採用510(k)送審
  • 在一般管控(general control)之外提供特殊管控(special control)給這些CADe醫材
  • 精簡CADe審查過程。

適用醫材用在以下的醫學影響分析醫材(medical image analyzers)Mammography breast cancer, ultrasound breast lesions,radiograph lung nodules, Radiograph dental caries detection, postamendments。有興趣的朋友可以參考下面的最終規則。



The FDA Reclassifies Medical Image Analyzers, Including Computer-Assisted Detection (CADe) Devices
Today, the U.S Food and Drug Administration (FDA) issued a final order to reclassify certain radiological medical image analyzers, including computer-assisted detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection devices, from Class III devices to Class II devices. ​
This final order: ​
Reclassifies ​certain CADe devices from Class III to Class II devices, subject to premarket notification (510(k)). ​Provides ​special controls that in addition to general controls, will provide a reasonable assurance of safety and effectiveness for CADe devices.Streamlines ​review for these types of computer-assisted detection devices and provides more timely access to these devices for patients.

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