Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 87

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 87
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Delay
by or failure of the FDA to grant our request for de 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 our business and subjects us to heightened regulation by the FDA and penalties for failure
to comply with these requirements.

Failure
by our laboratory to comply with applicable laws pertaining to LDTs or IVDs could adversely affect our business, results of operations,
and financial condition.

The
clinical laboratory testing sector is highly regulated in the U.S. PPLS, our laboratory, is accredited by CAP and holds a CLIA certificate
of accreditation. Any failure by our laboratory licensee to comply with CAP/CLIA requirements could result in adverse findings on inspection
that, if not timely corrected, could result in loss of accreditation and the inability to perform laboratory testing.

Additionally,
certain states, including California, Maryland, Nevada, Pennsylvania, and Rhode Island, require laboratories testing specimens from their
jurisdictions to hold an out-of-state laboratory license or permit. New York is exempt from, and imposes requirements in addition to,
CLIA, including a requirement for test-specific permits of LDTs before they can be