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人工智能加(jia)速 FDA 審查流程

作為一項(xiang)開創性舉措，FDA 正在利用生成式人工智能加快(kuai)其(qi)審查(cha)流(liu)程。這一舉措旨在提高效率，縮短評估(gu)新(xin)醫(yi)療器械和(he)治(zhi)療方法所需的時(shi)間。

一位專(zhuan)業(ye)人(ren)士分享了他們(men)的親(qin)身經歷(li)：

"I understand why. It has been an absolute game changer. This technology lets me complete tasks in minutes that used to take days. I have spent more time than I would like to admit on developing my custom-built AI agents and tools to suit my workflow."

他們重點介(jie)紹了幾個給他們的工(gong)作帶來變(bian)革(ge)的人(ren)工(gong)智能使用案例：

1. 實(shi)質(zhi)等同(tong)(tong)器械搜索：人工智能簡化了(le)對實(shi)質(zhi)等同(tong)(tong)器械的(de)搜索，使(shi)監(jian)管呈件更加高(gao)效(xiao)。

2. 科學文(wen)獻檢索：人工智(zhi)能擅長篩選大量科學文(wen)獻，快速提供(gong)相關(guan)信息。

3. 510(k) 數據庫分析：定(ding)制的(de)人(ren)工(gong)(gong)智能代(dai)理可以瀏(liu)覽510(k) 數據庫，查(cha)找人(ren)工(gong)(gong)查(cha)找耗時的(de)特定(ding)情況(kuang)。

4. 高級器械分(fen)類：人工智能驅動的(de)工具不僅能對產品代碼進行分(fen)類，還能幫助更好地組織和理解器械。

另一(yi)位(wei)專(zhuan)業人(ren)(ren)士(shi)強(qiang)調了(le)將人(ren)(ren)工智能(neng)融入更(geng)廣泛的戰略領域：

"Linking it with market access planning and reimbursement and revenue pathways. Regulatory crosswalks, optimal PCCP approaches to name a few."

一位評論者指出

"Wow, this is pretty cool! Last I heard, FDA reviewers were not allowed to use ChatGPT over fears of IP leakage. This makes sense, but why not for literature review? This is a use case I have found to be an extremely valuable use case for AI without disclosing confidential information to OpenAI and others."

"It's great to see people considering practical, non-sensitive applications of AI like this. Literature reviews could definitely benefit from AI's ability to quickly sift through vast amounts of data."

安全風險管理(li)和威脅建模

在醫療器械開發過程(cheng)中，人們越來(lai)越多地從(cong)威脅建(jian)模的角度來(lai)看(kan)待安(an)(an)全風(feng)險管理。AAMI TIR57 安(an)(an)全風(feng)險流程(cheng)與(yu)威脅建(jian)模宣言中的四(si)個關(guan)鍵問題完全一致：

1. 我們在(zai)做什么？

- 在安全風險(xian)管(guan)理計劃(hua)中定義系統和范圍(wei)。

2. 什么會出錯？

- 推動(dong)風險分析和評估。

3. 我們該怎么辦(ban)？

- 選擇并實施風險控(kong)制(zhi)措施，然后(hou)重新評估殘余風險。

4. 我們做得(de)足(zu)夠好嗎？

- 在風險(xian)管理(li)報告中記錄，并在生產(chan)和后期制作中持續監控(kong)。

美國食品(pin)和藥物(wu)管(guan)理局現在(zai)要求在(zai)提供 ISO 14971 安全文檔的同時(shi)提供單獨的安全風險文檔---沒有捷徑可走(zou)。

效率和清(qing)晰度：清(qing)晰的(de)一(yi)對一(yi)映(ying)射可避免重復工作(zuo)，并為審核人員提供他們所需(xu)的(de)準確(que)信息。

作為(wei)醫療器械的(de) SDK

另(ling)一(yi)種創新(xin)策略是將軟(ruan)件開發(fa)包(Software Development Kit, SDK)作為醫療器(qi)(qi)械部署(shu)。制(zhi)造商不需要獲得整套醫療器(qi)(qi)械的許(xu)可(ke)，而是將核心(xin)圖(tu)像分析(xi)組件作為 SDK 清關，然(ran)后其他(ta)開發(fa)人員就可(ke)以(yi)將其集成進(jin)來(lai)。

優點

減(jian)輕驗證(zheng)負擔：使用 SDK 的客戶無需進行大量研(yan)究(jiu)。

靈活(huo)性：允許更(geng)廣(guang)泛(fan)地采用并集(ji)成到(dao)各種應用中。

該領域的專家強調：

"Rather than getting a completed medical device cleared, this manufacturer decided to just clear the core image analysis component instead. It would decrease the validation burden on the customer of this SDK because they would not need to run another 527 participant study."

"Actually, this is a market of products that are SDKs used by third-party apps like telemedicine. The question goes if the telemedicine app can be marketed without being cleared also itself. How the final interface is presented to the user is a factor that impacts overall performance of the combination."

"Indeed a very elegant way. Only nitpick is that I wouldn't call it SOUP since its provenance is very well known."

本文(wen)由廣州佳(jia)譽醫療(liao)器械(xie)有限公司/佛山浩揚醫療(liao)器械(xie)有限公司聯合編輯