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

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 25
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 the FDA. Failure to comply with applicable requirements may subject a device and/or
its manufacturer to a variety of administrative and judicial sanctions, such as FDA refusal to approve pending premarket approval (“PMA”)
applications, issuance of warning letters or untitled letters, mandatory product recalls, import detentions, civil monetary penalties,
and/or judicial sanctions, such as product seizures, injunctions, and criminal prosecution.

Laboratory
Developed Tests

CyPath® Lung completed its certification as an LDT in accordance
with CAP and CLIA regulations and guidance in 2023. The FDA considers LDTs to be tests that are developed, validated, and performed within
a single laboratory. While CMS oversees clinical laboratory operations through the CLIA program, the FDA has the authority to regulate
LDTs as IVDs under the FDCA. On May 6, 2024, FDA promulgated a final rule phasing out over four years its enforcement discretion over
LDTs. The agency said 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 CyPath® Lung in any manner that will change its indications for use, alter its operating principal, include different
technology, or change its performance or safety specifications.

Clinical
Laboratory Improvement Amendments of 1988

Clinical
laboratories testing specimens collected in the U.S. for the purpose of disease diagnosis or health assessment are subject to CLIA, unless
exempt. CLIA establishes quality standards for all clinical laboratory testing to ensure the accuracy, reliability, and timeliness of
patient test results regardless of where the test was performed. In particular, these regulations mandate that clinical laboratories
must be certified by the federal government or an accreditation organization with deemed status from the federal government or must
be located in a state that has been granted exemption from CLIA requirements because the state has laws in effect that provide