Table 1.

Types of Food and drug administration (FDA) approvals for AI/ML-based healthcare technology are described [177].

SN	FDA Approval Stages	Description
1	510 (k) clearance	A 510 (k) authorization is granted to an algorithm if it is at least as secure and effective as another equivalent, commercially available algorithm. Alongside the claim, the applicant for this clearance must provide substantial proof of equivalence. It is illegal to commercialize the algorithm that is awaiting approval until it has been determined to be reasonably comparable to the other algorithm.
2	Premarket approval	For Class III medical devices, algorithms receive premarket approval. The safety and efficacy of the latter are assessed through more comprehensive scientific and regulatory processes since they can have a significant impact on human health. The FDA must find sufficient scientific evidence supporting the device’s usefulness and safety before approving an application. The applicant can move further with product marketing after receiving approval.
3	de novo pathway	The de novo category is used to categorize novel medical devices with sufficient safety and efficacy and with broad controls, but in which there are no lawfully marketed equivalents. Before approving and permitting the devices to be marketed, the FDA conducts a risk-based evaluation of the device.