Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 524

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 524
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 population
or for a longer period of use. In such cases, the manufacturer might be required to follow certain patient groups for a number of years
and to make periodic reports to the FDA on the clinical status of those patients. Failure to comply with the conditions of approval can
result in material adverse enforcement action, including withdrawal of the approval.

Certain changes to an approved
device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the design performance specifications,
which affect the safety or effectiveness of the device, require submission of a PMA supplement. PMA supplements often require submission
of the same type of information as a PMA, except that the supplement is limited to information needed to support any changes from the
device covered by the original PMA and may not require as extensive clinical data or the convening of an advisory panel. Certain other
changes to an approved device require the submission of a new PMA, such as when the design change causes a different intended use, mode
of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be
developed, and the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable assurance
of safety and effectiveness. None of our products are currently marketed pursuant to a PMA.

On November 10, 2020 we submitted
a PMA application to the FDA for the use of LungFit® PH in PPHN and subsequently received PMA approval in June 2022.

22

De-Novo Pathway. Another
pathway, known as de-novo down-classification also can be used for lower risk devices for which there is no existing product code or predicate
device. The Food and Drug Administration Modernization Act of 1997 established the de-novo down-classification procedure as a new route
to market for low to moderate risk medical devices that automatically require a PMA due to the absence of a predicate device. This procedure
allows a manufacturer whose novel device automatically requires a PMA to request down-classification of its medical device (to allow clearance
through the 510(k) pathway) on the basis that the device presents low or moderate risk, rather than requiring the submission and approval
of a PMA application. Manufacturers can request de-novo down-classification directly without first submitting a 510(k) premarket notification
to the FDA and receiving a “not substantially equivalent” determination. Under this pathway,