【法規工具文】Quick-guide on Software Pre-Cert Program (1) - Freiheit als Autonomie as an essence

【導讀】本文最初用英文寫作，目的是保留FDA原意。而本版的目的為工具用文章，故用中文註釋以便快速抓到重點，但細節部分還是建議細讀英文說明

個人這裡做一個貫穿的概述：

Pre-cert Program是因應現代快速的軟體開發環境而生，提供一個敏捷，更有彈性，甚至簡化的流程，但同時設法保障軟體產品品質。

其對組織要求有CQOE這5個基本原則，組織評鑑過程以此為參考。

這個Program由四大元件構成，以TPLC手法串接這四大元件。

所以請記住CQOE，TPLC這個關鍵字

Series of studies will be conducted on “The Software Precertification Pilot Program version 1.0 Working Model”, released by FDA, and will be summarized as quick guide reference.

This program provides an agile paradigm to accommodate the faster rate of development of SaMD. But quality requirements like CQOE are highly addressed.

Freiheit als Autonomie (Freedom as Autonomy) can be concluded as the essence of Pre-Cert Program.

【導讀】核心原則，CQOE（Culture of Quality and Organizational Excellence）品質文化與組織機構卓越性。 FDA再給予廠商彈性之前，一定會確認廠商是否合乎資格，CQOE就是評鑑的原則。

其與只有涉略到Pre-Market及產品資料Level的傳統方式最大不同在於， 四大元件+TPLC的手法涉及了Pre-Market與Post Markt, 組織與產品資料Level.It starts with CQOE

An agile regulatory paradigm is necessary to accommodate the faster rate of development and potential for innovation in software-based products.

The Software Precertification (Pre-Cert) Program is envisioned as a voluntary pathway that embodies regulatory model more tailored than the current regulatory paradigm to assess the safety and effectiveness of software technologies without inhibiting patient access to these technologies.

The program goal is to provide more streamlined and efficient regulatory oversight of software-based medical devices from manufacturers who have demonstrated a robust culture of quality and organizational excellence (CQOE) and are committed to monitoring real-world performance.

【導讀】COQE的五個原則，產品品質：病患安全：臨床責任：網絡安全責任：主動性文化。法規對產品的的要求就是保障功效性及安全性

General Requirements: FIVE CQOE principles

The culture of quality and organizational excellence (CQOE) principle is shown in Fig1. These principles will be applied as an assessment in organization level review in a Total Product Life Cycle (TPLC).

【導讀】Program的架構由四大元件構成,Excellence Appraisal (卓越性評鑑），Review Determiniation (審查方式決定），Streamlined Review (精簡審查）， 及Real-World Perfromance (真實世界表現）。

Four Components of Pre-cert program

The program consists of four interdependent program components, shown as Figure 2.

【導讀】Program的架構由四大元件構成，由TPLC（Total Product Life Cycles,全產品生命週期）的手法來執行。 可參考 Fig 3. TPLC可視為未來醫療軟體(SaMD)產品法規的重點。

Pre-Cert Program achieved by TPLC approach

The goal and vision of the Software Pre-Cert Program can be achieved by applying a Total Product Lifecycle (TPLC) approach, shown as Fig 3, to the regulation of software products.

This TPLC approach is briefed as below.

(1) All the four Software Pre-Cert Program components indicate corresponding stages.

(2) The cycle contains two levels analysis, organization and product. Each level are indicated with difference colors.

Visual comparisons between traditional pathway and Pre-cert pathway is illustrated as Fig 4. The key difference is that Pre-cert is throughout TPLC.

The difference between Traditional and Pre-cert program is summarized in Table 1. Pre-cert one involves organization/ product level, and pre-market/post-market data since it is proceed with TPLC approach.

【導讀】Pre-Cert的輪廓可參考Fig 5. 其描述4大元件如何被TPLC串起來，每個元件的產出有個簡要的說明。 Table 2 就每個元件的產出及被審核的層面做個列舉。

相對現行的FDA審核主要以產品面為主，Pre-Cert則涵蓋組織面與產品面。

Fig.6特別指出SR(Streamlined Review)精簡審核與現行審核機制的差異。

Outlining

The Precertification Program is simply a pathway, Fig 5, to access and evaluate necessary information at different points in the product’s lifecycle, to establish a reasonable assurance of safety and effectiveness for the product.

In comparison with Existing Generic Approach, notable process simplification can be found in Streamlined Review (SR) as illustrated in Fig 6.

【導讀】可以看到FDA的基本精神在於，開發廠商的產品開發品質系統需符合CQOE的原則，才能確保產品的安全性及功效性.

只有被FDA認可符合Pre-Cert level的廠商，FDA才能就對應的程度可以對應的彈性。

PreFreiheit als Autonomie

As it can be found, Pre-Cert program offers an agile paradigm granting manufacturers more flexibility but with prerequisite of CQOE qualification.

Immanuel Kant said, Freiheit als Autonomie (Freedom as Autonomy). It concludes the essence of Pre-Cert program.