Company: AEMD
Filing Date: 2025-09-05
Form Type: 424B4
Source: 0001683168-25-006701
Chunk: 25

Company: AETHLON MEDICAL INC
Filing Date: 2025-09-05
Form: 424B4
Chunk 25
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 in, or disapprove research to protect the rights, safety and welfare
of human research subjects. The FDA or the IRB at each site at which a clinical trial is being performed may withdraw approval of a clinical
trial at any time for various reasons, including a belief that the risks to study subjects outweigh the benefits or a failure to comply
with FDA or IRB requirements. Even if a trial is completed, the results of clinical testing may not demonstrate the safety and effectiveness
of the device, may be equivocal or may otherwise not be sufficient to obtain approval or clearance of the product.

| 12 |

Ongoing Regulation by the FDA

Even after a device receives
clearance or approval and is placed on the market, numerous regulatory requirements apply. Even after a device receives clearance or
approval and is placed on the market, numerous regulatory requirements apply. These include:

| · | establishment registration                                                                                                          
 and device listing;                                                                                                                 |
| · | the QSR, which requires                                                                                                             
 manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality   
 assurance procedures during all aspects of the manufacturing process;                                                               |
| · | labeling regulations and                                                                                                            
 the FDA prohibitions against the promotion of products for uncleared, unapproved or “off-label” uses and other requirements         
 related to promotional activities;                                                                                                  |
| · | medical device reporting                                                                                                            
 regulations, which require that manufactures report to the FDA if their device may have caused or contributed to a death or serious 
 injury, or if their device malfunctioned and the device or a similar device marketed by the manufacturer would be likely to cause   
 or contribute to a death or serious injury if the malfunction were to recur;                                                        |
| · | corrections and removal                                                                                                             
 reporting regulations, which require that manufactures report to the FDA field corrections or removals if undertaken to reduce a    
 risk to health posed by a device or to remedy a violation of the FDCA that may present a risk to health; and                        |
| · | post market surveillance                                                                                                            
 regulations, which apply to certain Class II or III devices when necessary to protect the public health or to provide additional    
 safety and effectiveness data for the device.                                                                                       |

Some changes to an approved PMA
device, including changes in indications, labeling or manufacturing processes or facilities, require submission and FDA approval of a
new PMA or PMA supplement, as appropriate, before the change can be implemented. Supplements to a PMA often require the submission of
the