各位朋友，大家新年快樂!最近發生了很多事，愛姆斯想寫點什麼，但還是留給之後好了!祝大家新的一年一樣能平平安安。
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。
參考
| 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. |
