Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 37

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 37
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 promotion, industry-sponsored
scientific and educational activities, and promotional activities involving the internet. A drug may be marketed only for the approved
indications and in accordance with the provisions of the approved labeling.

Adverse
event reporting and submission of periodic safety summary reports is required following FDA approval of an NDA. The FDA also may require
postmarket testing, known as Phase 4 testing, REMS, and surveillance to monitor the effects of an approved product, or the FDA may place
conditions on an approval that could restrict the distribution or use of the product. In addition, quality control, product manufacture,
packaging, and labeling procedures must continue to conform to cGMP after approval. Drug manufacturers and certain of their subcontractors
are required to register their establishments with the FDA and certain state agencies.

Registration
with the FDA subjects entities to periodic unannounced inspections by the FDA, during which the agency inspects a drug product’s
manufacturing facilities to assess compliance with cGMP. Accordingly, manufacturers must continue to expend time, money, and effort in
the areas of production and quality control to maintain compliance with cGMP. Regulatory authorities may withdraw product approvals or
request product recalls if a company fails to comply with required regulatory standards, if it encounters problems following initial
marketing, or if previously unrecognized problems are subsequently discovered.

 20 

European
Union

A
medical device or diagnostic test must be CE marked to be sold in the EU. The In Vitro Diagnostic Device Regulation (“IVDR”)
of the EU defines the necessary pre-conditions that must be fulfilled to CE mark an IVD test or in vitro medical device in the EU. The
manufacture of the test and/or device must fulfill all applicable regulatory requirements in the IVDR. Objective evidence of fulfilment
of these requirements must be provided by the manufacturer prior to placing a test on the EU market. The manufacturer is required to
establish a Quality Management System (“QMS”) as well as processes for manufacturing, importing, distribution, post-market
surveillance, and vigilance. Regulations also require that the product is fully documented. In addition, it is likely that our CyPath®
Lung test is classified in a risk class that requires a review by an external party, a Notified Body, prior to placing the test
on the EU market. This process is expected to require an additional six to 12 months after required documents and systems are in place.
There currently is a general shortage in the EU of available Notified