Company: AEMD
Filing Date: 2025-09-05
Form Type: 424B4
Source: 0001683168-25-006701
Chunk: 24

Company: AETHLON MEDICAL INC
Filing Date: 2025-09-05
Form: 424B4
Chunk 24
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 the Quality System Regulation,
or QSR. The agency also may inspect one or more clinical sites to assure compliance with FDA’s regulations.

Upon completion of the PMA review,
the FDA may: (i) approve the PMA which authorizes commercial marketing with specific prescribing information for one or more indications,
which can be more limited than those originally sought; (ii) issue an approvable letter which indicates the FDA’s belief that
the PMA is approvable and states what additional information the FDA requires, or the post-approval commitments that must be agreed to
prior to approval; (iii) issue a not approvable letter which outlines steps required for approval, but which are typically more
onerous than those in an approvable letter, and may require additional clinical trials that are often expensive and time consuming and
can delay approval for months or even years; or (iv) deny the application. If the FDA issues an approvable or not approvable letter,
the applicant has 180 days to respond, after which the FDA’s review clock is reset.

Emergency Use Authorizations,
or EUAs, are granted by FDA in public health emergencies but allow use of the authorized device only during the period of the respective
public health emergency, and do not change the requirement to ultimately seek PMA approval after the authorization period has ended.

Clinical Trials

Clinical trials are almost always
required to support pre-market approval and are sometimes required for 510(k) clearance. In the United States, for significant risk devices,
these 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