Company: AEMD
Filing Date: 2025-08-20
Form Type: S-1
Source: 0001683168-25-006352
Chunk: 28

Company: AETHLON MEDICAL INC
Filing Date: 2025-08-20
Form: S-1
Chunk 28
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 trials require submission 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.

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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