Company: AEMD
Filing Date: 2025-07-25
Form Type: DRS
Source: 0001683168-25-005397
Chunk: 28

Company: AETHLON MEDICAL INC
Filing Date: 2025-07-25
Form: DRS
Chunk 28
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 of an application for an IDE to the FDA. The IDE application must be supported by appropriate
data, such as animal and laboratory testing results, showing it is safe to test the device in humans and that the testing protocol is
scientifically sound. The IDE must be approved in advance by the FDA for a specific number of patients at specified study sites. During
the trial, the sponsor must comply with the FDA’s IDE requirements for investigator selection, trial monitoring, reporting and recordkeeping.
The investigators must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control the disposition
of investigational devices and comply with all reporting and recordkeeping requirements. Clinical trials for significant risk devices
may not begin until the IDE application is approved by the FDA and the appropriate institutional review boards, or IRBs, at the clinical
trial sites. An IRB is an appropriately constituted group that has been formally designated to review and monitor medical research involving
subjects and which has the authority to approve, require modifications 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.

| 11 |

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