Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 29

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 29
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 safe and effective for its intended use(s). After completion of clinical
testing, a PMA including the results of all non-clinical, clinical, and other testing and information relating to the product’s
marketing history, design, labeling, manufacture, and controls, is prepared and submitted to the FDA.

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The
PMA approval process is generally more expensive, rigorous, lengthy, and uncertain than the 510(k) premarket notification process and
de novo classification process and requires proof of the safety and effectiveness of the device to the FDA’s satisfaction.
As part of the PMA review, the FDA will typically inspect the manufacturer’s facilities for compliance with Quality System Regulation
(“QSR”) requirements, which impose elaborate testing, control, documentation, and other quality assurance procedures. The
FDA has a user fee goal to review a PMA in 180 calendar review days if the submission does not require advisory committee input, or 320
review days if the submission does require advisory committee input. During the process, the FDA may issue a major deficiency letter,
which stops the review clock. The applicant has up to 180 days to respond. Therefore, the total review time could be up to 360 days,
if the submission does not require advisory committee input, or 500 days if the submission does require advisory committee input, and
in practice may be longer. The COVID-19 pandemic significantly increased the FDA’s workload because of the need to review emergency
use authorization requests for IVDs and other regulated products, which delayed review timelines for some non-COVID-19 products.

If
the FDA’s evaluation of the PMA application is favorable, the FDA will issue a PMA for the approved indications, which can be more
limited than those originally sought by the manufacturer. The PMA can include post-approval conditions that the FDA believes necessary
to ensure the safety and effectiveness of the device including, among other things, restrictions on labeling, promotion, sale, and distribution
or a requirement for postmarket surveillance or completion of postmarket studies. Failure to comply with the conditions of approval can
result in material adverse enforcement action, including the loss or withdrawal of the approval and/or placement of restrictions on the
sale of the device until the conditions are satisfied.

Even
after approval of a PMA, a new PMA or PMA supplement may be required in the event of a modification to the device, its labeling, or its
manufacturing process. Supplements to a PMA may require the