Company: AEMD
Filing Date: 2025-08-29
Form Type: S-1/A
Source: 0001683168-25-006537
Chunk: 29

Company: AETHLON MEDICAL INC
Filing Date: 2025-08-29
Form: S-1/A
Chunk 29
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 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 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 device covered by the original PMA. The FDA uses the same procedures and actions in reviewing
PMA supplements as it does in reviewing original PMAs.

Failure by us or by our suppliers
to comply with applicable regulatory requirements can result in enforcement action by the FDA or state authorities, which may include
any of the following sanctions:

| · | warning or untitled letters, fines, injunctions, consent decrees and civil penalties;                   |
| · | customer notifications, voluntary or mandatory recall or seizure of our products;                       |
| · | operating restrictions, partial suspension or total shutdown of production;                             |
| · | delay in processing submissions or applications for new products or modifications to existing products; |
| · | withdrawing approvals that have already been granted; and                                               |
| · | criminal prosecution.                                                                                   |

| 13 |

The Medical Device Reporting laws
and regulations require us to provide information to the FDA when we receive or otherwise become aware of information that reasonably
suggests our device may have caused or contributed to a death or serious injury as well as a device malfunction that likely would cause
or contribute to death or serious injury if the malfunction were to recur. In addition, the