I've been meaning to post this for a while. Having extra time on my hands starting around March, I began a deep research dive into the FDA to understand the hang up with ECG and other features long missing. This post serves as an info dump, for anyone that's curious. This is several months of research analysing databases, FOIA requests and others. I will do my best to parse useful info, add relevent links and provide my best non-professional interpretation where needed. Let me know if you have questions and I can help. The issue has been the lack of FDA clearance for a year now, and the lack of response by Samsung and moderators on here, and the industry as a whole. We've all been left in the dark for a year now and its sucked. While searching, I was unable to find any approvals for Samsung wearables. I had sought out via FOIA any filed applications, but I never found any. Here's what I have learned. The hardware for the ECG function is made by a third party called VectraCor Inc. located in New Jersey. Their hardware was FDA approved in August 2018 and is the same hardware found in Apple watches. Their 510(k) number is K173952 and their filing can be found here - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K173952 For our watches, and Apples, the approval needed isn't for the hardware, but rather the software and app we interact with and displays the information. This is known as, Electrocardiograph Software for Over the Counter Use. Under regulation 870.2345 and Product Code QDA as a Class 2 Device. Both Samsung and Apple only need to demonstrate that the apps are, and operate Substantially Equivalent to other similar products, also known shorthand as SESE. This is a 90 day process from application to approval. For reference, you can see Apples approval filed under their 513(f)(2)(De Novo) number DEN180044 here -https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?ID=DEN180044 There's a lot more to share, but the last bit worth mentioning is the recent FDA approval for Samsung. Under the same 870.2345 regulation for QDA Class 2 Device filing, Samsung's ECG app was submitted June 1, 2020 and approved on August 4, 2020. It can be found under their 510(k) number K201168 here - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201168 Again, this represents a fraction of the information I've gathered, but I wanted to share it with all of you for your own interpretation or research purposes. It's good news, and means a near future update will likely include the ECG function, and others we've all be waiting for. What I haven't been able to uncover, at least with any clarity or certainty, is why it took almost a year to submit the application. This is likely an internal Samsung thing, so we'll likely never find out. Either way, hope y'all enjoy the functions when the get released soon, they will be coming as an app update and likely here very soon before the end of the year.
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