Special 510(k) 是US FDA目前既有的醫療器材法規途徑，當廠商已核准上市之產品發生設計變更時，FDA無須重頭審查變更後的產品，廠商可選擇審查流程較為簡化的Special 510(k)，但是當設計變更的範圍包含了以下情況則無法走Special 510(k)！
在2018/11/08 US FDA招開了webinar，即是在說明Special 510(k) Program Pilot的實施辦法與適用對象，最後讓我們一起聽聽FDA的介紹吧：
1. 適應症變更；
2. 改變了產品的技術基本原理(Fundamental Scientific Technology)
不過US FDA有在考量放寬以上的限制條件！
在2018/10/01 US FDA推出了Special 510(k) Program Pilot，目的在擴大可適用的變更類型以加速510(k)的審查效率，在這個Program Pilot中FDA要求廠商自行分析/評估預計進行的設計變更項目，是否需要進行performance test? 以及有無well-established method來驗證?
在2018/11/08 US FDA招開了webinar，即是在說明Special 510(k) Program Pilot的實施辦法與適用對象，最後讓我們一起聽聽FDA的介紹吧：
您好，請問在 September 13, 2019 發布的 下列說明中，是否說明了 "就算修改了 Intended Use，也可能可以申請 Special 510(k)" 呢？
回覆刪除"The Special 510(k) Program was previously limited to review of changes that did not affect the device’s intended use nor alter the device’s fundamental scientific technology. Under this approach, Special 510(k)s that included modifications to the indications for use or any labeling change that affected the device’s intended use and/or modifications that had the potential to alter the fundamental scientific technology of the device compared to the manufacturer’s own legally marketed predicate device5 were routinely converted to Traditional 510(k)s. FDA now no longer intends to focus on changes that affect indications for use or alter fundamental scientific technology in determining whether the 510(k) is appropriate as a Special 510(k). Instead, FDA’s approach focuses on whether the method(s) to evaluate the change(s) are well-established, and whether the results can be sufficiently reviewed in a summary or risk analysis format."
您好，請教您看的應該是這份"Guidance - The Special 510(k) Program"吧:
刪除https://www.fda.gov/media/116418/download
正如您擷取的內容中所提到的，US FDA調整了Special 510(k) 的評估流程，不在以changes that did not affect the device’s intended use nor alter the device’s fundamental scientific technology為唯一準則，不過我不認為這代表可以隨意更改intended use之內容，在這份guidance中有清楚地探討Special 510(k)更新後的評估標準與流程，您可以先衡量一下預計的intended use變更，能否走Special 510(k)！