Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 30

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 30
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 submission of the same type of information required for an original PMA,
except that the supplement is generally limited to that information needed to support the proposed change from the product covered by
the original PMA.

Clinical
Trials

Generally,
at least one clinical trial is required to support a PMA application. Clinical studies also may be required for de novo classification
or a 510(k) premarket notification. Clinical trials may also be conducted or continued to satisfy post-approval requirements for devices
with PMAs. For significant risk investigational device studies, the FDA regulations require that human clinical investigations conducted
in the U.S. be subject to an approved investigational device exemption (“IDE”). An IDE application is considered approved
30 days after it has been received by the FDA, unless the FDA otherwise informs the sponsor prior to that time that the IDE is approved,
approved with conditions, or disapproved. A nonsignificant risk investigational device study does not require FDA approval of an IDE.
Some types of device studies, including many IVD studies, are exempt from IDE requirements altogether.

Clinical
trials must be conducted in accordance with good clinical practice (“GCP”) requirements contained in federal regulations
and in international guidelines. Clinical trials, for both significant and nonsignificant risk devices, as well as exempt studies, must
be approved by an IRB, an appropriately constituted group that has been formally designated
to review and monitor biomedical research involving human subjects and which has the authority to approve, require modifications in,
or disapprove research to protect the rights, safety, and welfare of the human research subject.

The
FDA may order the temporary or permanent discontinuation of a clinical trial at any time or impose other sanctions, if it believes that
the clinical trial either is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical
trial patients. An IRB may also require the clinical trial it has approved to be halted, either temporarily or permanently, for failure
to comply with the IRB’s requirements or may impose other conditions or sanctions.

Although
the QSR does not fully apply to investigational devices, the requirement for controls on design and development does apply. The sponsor
also must manufacture the investigational device in conformity with the quality controls described in the IDE application and any conditions
of IDE approval that the FDA may impose with respect to manufacturing.

Postmarket
Requirements

After
a device is placed on the market, numerous general regulatory controls apply. These include the QSR, labeling regulations, medical