Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 521

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 521
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 regulates drug and medical device products under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”),
and its implementing regulations. Our products have been designated as devices by the FDA and will be regulated by the Center for Devices
and Radiological Health (“CDRH”). Given that currently approved NO products and delivery systems were approved either separately
(NO drug approval and NO delivery systems cleared as devices) or as drug-device combinations in the United States, we expect our device
to not only be reviewed by CDRH, but also have input from the Center for Drug Evaluation and Research (“CDER”).

FDA Premarket Clearance and
Approval Requirements for Medical Devices. Unless an exemption applies, each medical device commercially distributed in the United
States requires either FDA clearance of a 510(k) premarket notification, authorization of a de novo application, or approval of a PMA
application. Under the FD&C Act, medical devices are classified into one of three classes—Class I, Class II or Class III—depending
on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its safety
and effectiveness. Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness can be
assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of
the Quality System Regulation (“QSR”) facility registration and product listing, reporting of adverse medical events, and
truthful and non-misleading labeling, advertising, and promotional materials. Class II devices are subject to the FDA’s General
Controls, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. These special controls
can include performance standards, post-market surveillance, patient registries and FDA guidance documents.

While most Class I devices are
exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a
premarket notification under Section 510(k) of the FFDCA requesting permission to commercially distribute the device. The FDA’s
permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance. Devices
deemed by the FDA to pose the greatest risks, such as life sustaining, life supporting or some implantable devices, or devices that have
a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed in