apple跟FDA的連結都在這裡，你們自己看。
吵FDA認證好無聊。
看英文就知道apple watch的ECG是什麼東西，不難懂啊。
他只是一個app。
apple文件下載點： https://www.apple.com/healthcare/site/docs/Apple_Watch_Arrhythmia_Detection.pdf
FDA文件下載點：FDA給予apple ECG App的文件說明
FDA:
The ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG. The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias.
The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment.
APPLE:
Overview
With the availability of watchOS 5.1.2 and Apple Watch Series 4, Apple Watch customers now have access to two features to detect heart arrhythmias such
as atrial fibrillation. Apple Watch Series 1 and later can look for arrhythmias using a photoplethysmograph-based algorithm, and the ECG app on Apple Watch Series 4 is capable of generating an ECG similar to a Lead I electrocardiogram. This app also classifies an ECG as sinus rhythm (SR), atrial fibrillation (AF), or inconclusive, and reports high or low heart rate. This paper is intended to provide a more detailed understanding of the capabilities of these features, including testing and validation.
Medical Device De Novo Classification Process的公開文件
The De Novo classification process is intended to provide an efficient pathway to ensure the most appropriate classification of a device consistent with the protection of the public health and the statutory scheme for device regulation.
財團法人醫藥品查驗中心:
http://www.cde.org.tw/Content/Files/Knowledge/e5a179f4-2ba6-415b-ae2e-05bf0e162b5f.pdf
FDA給Apple的文件，以及De Novo classification的中文說明.zip
個人解讀：
ECG.app是De Novo classification，不具有實質等同性(substantial equivalent)。 所以，他們文件都宣稱ECG.app是一種創新的單通道(single channel detector)搭配AI演算法應用。所以預設搭配ECG.app的apple watch，得到一個具有ECG.app的硬體裝置。實質看文件內容可以發現，這個ECG.app軟體是FDA給予的標示，而非手錶本體。
分開看，
假設ECG.app是販售的app軟體，在apple store裡面做app上架，請問政府會管嗎？
或是發文限制apple不准給使用者下載這個app，以及不准app具有健康功能嗎？
心律app可以，但是ECG app卻不可？兩套標準。
講穿了就因為watch內建app，所以搭配組合，政府就是要管device裝置。
但，他管不了app，只要ECG.app是 apple store販售或是下載，由使用者決定就好，這就可以迴避ECG.app的審查。
