Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 522

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 522
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Class III, requiring approval of a PMA. Some pre-amendment devices are unclassified, but are subject to FDA’s premarket notification
and clearance process in order to be commercially distributed.

510(k) Clearance Marketing
Pathway. To obtain 510(k) clearance, a company must submit to the FDA a premarket notification submission demonstrating that the proposed
device is “substantially equivalent” to a predicate device already on the market. A predicate device is a legally marketed
device that is not subject to PMA, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for which
a PMA is not required, a device that has been reclassified from Class III to Class II or I, or a device that was found substantially equivalent
through the 510(k) process. The FDA’s 510(k) clearance process usually takes from three to twelve months, but often takes longer.
The FDA may require additional information, including clinical data, to make a determination regarding substantial equivalence. In addition,
the FDA collects user fees for certain medical device submissions and annual fees for medical device establishments.

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If the FDA agrees that the device
is substantially equivalent to a predicate device currently on the market, it will grant 510(k) clearance to commercially market the device.
If the FDA determines that the device is “not substantially equivalent” to a previously cleared device, the device is automatically
designated as a Class III device. The device sponsor must then fulfill more rigorous PMA requirements or can request a risk-based classification
determination for the device in accordance with the “de novo” process, which is a route to market for novel medical devices
that are low to moderate risk and are not substantially equivalent to a predicate device.

After a device receives 510(k)
marketing clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change
or modification in its intended use, will require a new 510(k) clearance or, depending on the modification, PMA approval. The FDA requires
each manufacturer to determine whether the proposed change requires submission of a 510(k) or a PMA in the first instance, but the FDA
can review any such decision and disagree with a manufacturer’s determination. If the FDA disagrees with a manufacturer’s
determination, the FDA can require the manufacturer to cease marketing and/or request the recall of the modified device until 510(k) marketing
clearance, authorization of