Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 529

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 529
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ologic/device, drug/biologic, or drug/device/biologic,
that are combined or mixed and produced as a single entity; packaged together in a single package or as a unit; or a drug, device, or
biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an
approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or
effect.

To determine which FDA center
or centers will review a combination product candidate submission, companies may submit a request for assignment to the FDA. Those requests
may be handled formally or informally. In some cases, jurisdiction may be determined informally based on FDA experience with similar products.
However, informal jurisdictional determinations are not binding on the FDA. Companies also may submit a formal Request for Designation
to the FDA Office of Combination Products. The Office of Combination Products will review the request and make its jurisdictional determination
within 60 days of receiving a Request for Designation.

FDA will determine which center
or centers within the FDA will review the product candidate and under what legal authority the product candidate will be reviewed. Depending
on how the FDA views the product candidates that are developed, the FDA may have aspects of the product candidate reviewed by the Center
for Biologics Evaluation and Research (“CBER”), CDRH, or CDER, though one center will be designated as the center with primary
jurisdiction, based on the product candidate’s primary mode of action. The FDA determines the primary mode of action based on the
single mode of action that provides the most important therapeutic action of the combination product candidate – the mode of action
expected to make the greatest contribution to the overall intended therapeutic effects of the combination product candidate. The review
of such combination product candidates is often complex and time-consuming, as the FDA may select the combination product candidate to
be reviewed and regulated by one or multiple of the FDA centers identified above, which could affect the path to regulatory clearance
or approval. Furthermore, the FDA may also require submission of separate applications to multiple centers.

The post-market requirements that
apply to the cleared or approved product will largely be aligned with the agency center determined to have primary jurisdiction over the
product candidate and that provided marketing authorization, but manufacturers must also comply with certain post-market requirements
with respect to the constituent parts of combination products. In April 2019, FDA published a final guidance document entitled Compliance
Policy for Combination Product Post-M