Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 27

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 27
---
    ●
    operating
    restrictions, partial or total shutdown of production facilities;

    ●
    refusal
    of or delay in granting requests for 510(k) clearance, de novo classification, or premarket approval of new products or modified
    products;

    ●
    withdrawing
    510(k) clearances, de novo classifications, or premarket approvals that are already granted;

    ●
    refusal
    to grant export approval or export certificates for devices; and

    ●
    criminal
    prosecution.

Premarket
Authorization and Notification

While
most Class I and some Class II devices may be marketed without prior FDA authorization, many Class II and most Class III medical devices
can be legally sold within the U.S. only if the FDA has: (1) approved a PMA application prior to marketing, generally applicable to most
Class III devices; (2) cleared the device in response to a premarket notification (a “510(k) submission”), generally applicable
to some Class I and most II devices; or (3) authorized the device to be marketed through the de novo classification process, generally
applicable for novel low- or moderate-risk devices. PMA applications, 510(k) premarket notifications, and de novo requests require
payment of user fees.

510(k)
Premarket Notification

Product
marketing in the U.S. for most Class II and a limited number of Class I devices typically follows the 510(k) premarket notification pathway.
To obtain 510(k) clearance, a manufacturer must submit a premarket notification demonstrating that the proposed device is substantially
equivalent to a legally marketed device, referred to as the “predicate device.” A predicate device may be a previously 510(k)
cleared device or a Class III device that was in commercial distribution before May 28, 1976, for which the FDA has not yet called for
PMA applications, or a product previously placed in Class II or Class I through the de novo classification process. The manufacturer
must show that the proposed device has the same intended use as the predicate device, and that it either has the same technological characteristics,
or has different technological characteristics but is shown to be equally safe and effective and does not raise different questions of
safety and effectiveness as compared to the predicate device.

The
FDA has a user fee goal to apply no more than 90 calendar review days to 510(k) submissions. During the process, the FDA may issue an
Additional Information request