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

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 31
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 device
reporting regulations (which require that manufacturers report to the FDA if their device may have caused or contributed to a death or
serious injury or malfunctioned in a way that would likely cause or contribute to a death or serious injury if it were to recur), and
reports of corrections and removals regulations (which require manufacturers to report recalls or removals and field corrections to the
FDA if initiated to reduce a risk to health posed by the device or to remedy a violation of the FDCA). Failure to properly identify reportable
events or to file timely reports, as well as failure to address each of the observations to the FDA’s satisfaction, can subject
a manufacturer to warning letters, recalls, or other sanctions and penalties.

Advertising,
marketing, and promotional activities for devices are also subject to FDA oversight and must comply with the statutory standards of the
FDCA and the FDA’s implementing regulations.

Manufacturers
of medical devices are permitted to promote products solely for the uses and indications set forth in the approved or cleared product
labeling. A number of enforcement actions have been taken against manufacturers that promote products for “off-label” uses
(i.e., uses that are not described in the approved or cleared labeling).

Violations
of the FDCA relating to inappropriate promotion of medical devices may also lead to investigations alleging violations of federal and
state healthcare fraud and abuse and other laws, as well as state consumer protection laws.

For
a PMA or Class II 510(k) or de novo device, the FDA also may require postmarketing testing, surveillance, or other measures to
monitor the effects of an approved or cleared product. The FDA may place conditions on a PMA-approved device that could restrict the
distribution or use of the product. In addition, quality control, manufacture, packaging, and labeling procedures must continue to conform
to the QSR after approval and clearance, and manufacturers are subject to periodic inspections by the FDA. Accordingly, manufacturers
must continue to expend time, money, and effort in the areas of production and quality control to maintain compliance with the QSR and
other applicable regulatory requirements. The FDA may withdraw product approvals or recommend or require product recalls if a company
fails to comply with regulatory requirements.

 18 

Therapeutic
Products

FDA
Approval Process

In
the U.S., therapeutic products are subject to extensive regulation by the FDA. The FDCA and other federal and state statutes and regulations,
govern, among other things, the research, development, testing, manufacture, storage