Company: BIAF
Filing Date: 2025-06-27
Form Type: POS AM
Source: 0001641172-25-016923
Chunk: 110

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-06-27
Form: POS AM
Chunk 110
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 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.

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; |

| 66 |

| ● | recall,                                                                                                                          
 detention, or seizure of products;                                                                                               |
| ● | operating                                                                                                                        
 restrictions, partial or total shutdown of production facilities;                                                                |
| ● | refusal                                                                                                                          
 of or delay in granting requests for 510(k) clearance, de novo classification, or premarket approval of new products or modified 
 products;                                                                                                                        |
|