A new Beginning..., page-2744

A lot of the earlier watches were consumer grade or only had clearances as apposed to approvals.

Also note the FDA is running a pre cert pilot programme for 9 digital health software companies. This apple beddit app may show up after. As well as the fit bit watch sleep tracking/ app, with spo2 sensor. Then they may be approved quicker with less info, testing or trials, or make changes to qualify.

It seems to give credibility to the company as a whole as well as meet quality certain standards to pre-certify the company, streamline the process in future etc. Reach some kind standard CQOE culture of quality and organizational excellence.

These companies over time may buy software SAMD and try and fast track it via being a certified company.

Have only skim read it there a lot to take in, links to other pages at bottom of article as well.
See article for full details,

https://www.fda.gov/medicaldevices/digitalhealth/digitalhealthprecertprogram/default.htm

Not investment advice, do your own research, and consult a licensed adviser