Re:Launch HN: SafeBeat Rx (YC S21)- At-home ECG software to ...
by neurotech1 on Tuesday August 24, 2021 @04:26PM
(#28294532)
They are referring to 510(k) Clearance [0]
> The 510(k) Clearance process is one of two ways by which a medical device manufacturer can obtain approval from the Food and Drug Administration, although legally, a device clearance under this section is not a true “approval.” 510(k) Clearance simply gives the company permission to market its product, based on comparison to a “predicate” [previously approved] device.[1]
Basically, If a somewhat similar device is already on the market, the FDA will clear the new device for the market.
> The 510(k) Clearance process is one of two ways by which a medical device manufacturer can obtain approval from the Food and Drug Administration, although legally, a device clearance under this section is not a true “approval.” 510(k) Clearance simply gives the company permission to market its product, based on comparison to a “predicate” [previously approved] device.[1]
Basically, If a somewhat similar device is already on the market, the FDA will clear the new device for the market.
[0] https://www.fda.gov/medical-devices/device-approvals-denials...
[1] https://www.levinlaw.com/fda-510k