Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 63

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 63
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, 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 would be required to submit a PMA to obtain marketing authorization,
which would require manufacturing information and a pre-approval inspection of the manufacturing facilities and could require review by
an FDA advisory panel comprised of experts outside the FDA. Any delay by or failure of the FDA to grant our de novo request or
PMA could adversely affect our consolidated revenues, results of operations, and financial condition.

Additionally, obtaining FDA marketing authorization,
approval, or de novo classification for diagnostics can be expensive, time consuming and uncertain, and for higher-risk devices
can take several years and require detailed and comprehensive scientific and clinical data. In addition, medical devices are subject to
ongoing FDA obligations and continued regulatory oversight and review. Ongoing compliance with FDA regulations increases the cost of conducting