Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 60

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 60
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 even though the FDA believes
it can impose regulatory requirements on LDTs, such as requirements to obtain premarket approval, de novo classification, or clearance
of LDTs, it has generally chosen not to enforce those requirements. The FDA has, on occasion, sent warning letters to laboratories offering
LDTs that the agency believed were not eligible for enforcement discretion because of how they were developed, validated, performed, or
marketed and consequent risks to the public.

On May 6, 2024, FDA promulgated a final rule phasing
out over four years its enforcement discretion over LDTs. The agency states it will expect compliance with premarket review and quality
system requirements for LDTs marketed after May 6, 2024. The FDA states that the agency will generally not enforce premarket review requirements
for LDTs that were marketed before May 6, 2024, if they are not modified in certain ways. In particular, the rule states that the LDT
is exempt if marketed before May 6, 2024, and is not modified in a way that changes its indications for use; does not alter its operating
principle; does not include significantly different technology; and, the LDT does not adversely change its performance or safety specifications.
The Company has no expectation or intention to modify CyPathLung in any manner that will change its indications for use,
alter its operating principal or include different technology, or change its performance or safety specifications.

| 27 |

Although we do intend to conduct clinical trials in
order to receive de novo classification from the FDA as a Class II in vitro diagnostic, there can be no assurance that the trial
will have favorable results or that it will generate the results necessary to obtain such clearance.

Delay by or failure of the FDA to grant our request forde novo classification, or failure on our part to comply with applicable requirements, would adversely affect our business, results of operations, and financial condition.

The FDCA requires that medical devices introduced
to the U.S. market, unless exempted by regulation, be authorized by the FDA pursuant to either the premarket notification pathway, known
as 510(k) clearance, the de novo classification pathway, or the premarket approval (“PMA”) pathway. We plan to seek
de novo classification for the CyPath Lung test in fiscal year 2028. The FDA may not agree that CyPath
Lung meets the criteria for de novo classification, in which case we