Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 26

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 26
---
 for requirements
equal to or more stringent than CLIA requirements. CLIA also requires that laboratories meet quality assurance, quality control and personnel
standards, perform proficiency testing, and undergo inspections. The CLIA standards applicable to clinical laboratories are based on
the complexity of the testing performed by the laboratory, which ranges from “waived” to “moderate complexity”
to “high complexity.” In the case of tests performed using IVDs, test complexity categorization of the IVD is performed by
the FDA.

CAP
is a member-based physician organization comprising approximately 18,000 board-certified pathologists. CAP’s Laboratory Accreditation
Program has been granted deeming authority from the federal government, meaning that CAP accreditation can be used to qualify for CLIA
certification and to satisfy CLIA inspection requirements.

Medical
Devices

The
FDCA classifies medical devices into one of three categories based on the risks associated with the device and the level of control necessary
to provide reasonable assurance of safety and effectiveness. Class I devices are low risk and are subject only to general regulatory
controls. Class II devices are moderate risk. They are subject to general controls and may also be subject to special controls. Class
III devices are generally the highest risk devices. They are required to obtain premarket approval and comply with postmarket conditions
of approval in addition to general regulatory controls.

Generally,
establishments that design and/or manufacture devices are required to register their establishments with the FDA. They also must provide
the FDA with a list of the devices that they design and/or manufacture at their facilities.

 16 

The
FDA enforces its requirements by market surveillance and periodic inspections, both announced and unannounced, to review records, equipment,
facilities, laboratories, and processes to confirm regulatory compliance. These inspections may include the manufacturing facilities
of subcontractors. Following an inspection, the FDA may issue a report, known as a Form 483 notice of observations, listing instances
where the manufacturer has failed to comply with applicable regulations and/or procedures. The FDA may also issue a public warning letter.
If the manufacturer does not adequately respond to a Form 483 or warning letter, the FDA may take enforcement action against the manufacturer
or impose other sanctions or consequences, which may include:

    ●
    cease
    and desist orders;

    ●
    injunctions,
    or consent decrees;

    ●
    civil
    monetary penalties;

    ●
    recall,
    detention, or seizure of products;