Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 28

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 28
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, which stops the clock. The applicant has 180 days to respond, although during the COVID-19 Public Health
Emergency, the FDA permitted companies an additional 180 days in which to respond. Therefore, the total review time absent the Public
Health Emergency could be up to 270 days, and in practice may be longer.

After
a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute
a major change in its intended use, requires a new 510(k) clearance or could require a PMA approval or de novo classification.
The FDA requires each manufacturer to make this determination in the first instance, but the FDA can review any such decision. If the
FDA disagrees with a manufacturer’s decision not to seek a new 510(k) clearance for the modified device, the agency may retroactively
require the manufacturer to seek 510(k) clearance, de novo classification, or PMA approval. The FDA also can require the manufacturer
to cease marketing and/or recall the modified device until 510(k) clearance or PMA approval is obtained.

De
Novo Classification

Devices
of a new type that the FDA has not previously classified based on risk are automatically classified into Class III regardless of the
level of risk they pose. To avoid requiring PMA review of novel low- to moderate-risk devices classified in Class III by operation of
law, Congress enacted a provision that allows the FDA to reclassify a novel low- to moderate-risk device into Class I or II in the absence
of a predicate device that would support 510(k) clearance. The FDA evaluates the safety and effectiveness of devices submitted for review
under this de novo pathway and devices determined to be Class II can serve as predicate devices for future 510(k) applicants.
The de novo pathway can require clinical data.

The
FDA has a user fee goal to review a de novo request in 150 calendar review days. During the process, the FDA may issue an Additional
Information request, which stops the clock. The applicant has 180 days to respond. Therefore, the total review time could be as long
as 330 days and in practice may be longer. During the COVID-19 public health emergency, applicants were given an additional 180 days
in which to respond.

PMA
Approval

A
Class III product generally must follow the PMA approval pathway. The PMA must be supported by sufficient valid scientific evidence,
including clinical study data, to assure that the device is