Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 525

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 525
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 the FDA is required to classify
the device within 120 days following receipt of the de-novo application. If the manufacturer seeks reclassification into Class II, the
manufacturer must include a draft proposal for special controls that are necessary to provide a reasonable assurance of the safety and
effectiveness of the medical device. In addition, the FDA may reject the reclassification petition if it identifies a legally marketed
predicate device that would be appropriate for a 510(k) or determines that the device is not low to moderate risk or that general controls
would be inadequate to control the risks and special controls cannot be developed.

Clinical Trials. Clinical
trials are almost always required to support a PMA and are sometimes required to support a 510(k) submission. All clinical investigations
of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s Investigational Device Exemption
(“IDE”) regulations which govern investigational device labeling, prohibit promotion of the investigational device, and specify
an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. If the device presents
a “significant risk,” to human health, as defined by the FDA, the FDA requires the device sponsor to submit an IDE application
to the FDA, which must become effective prior to commencing human clinical trials. A significant risk device is one that presents a potential
for serious risk to the health, safety or welfare of a patient and either is implanted, used in supporting or sustaining human life, substantially
important in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health, or otherwise presents
a potential for serious risk to a subject. An IDE application must be supported by appropriate data, such as animal and laboratory test
results, showing that it is safe to test the device in humans and that the testing protocol is scientifically sound. The IDE will automatically
become effective 30 days after receipt by the FDA unless the FDA notifies the Company that the investigation may not begin. If the FDA
determines that there are deficiencies or other concerns with an IDE for which it requires modification, the FDA may permit a clinical
trial to proceed under a conditional approval.

In addition, the study must be
approved by, and conducted under the oversight of, an Institutional Review Board (“IRB”) for each clinical site. The IRB is
responsible for the initial and continuing review of the IDE study, and may pose additional requirements for the conduct of the study.
If an IDE application is approved by