Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 572

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 572
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 or cleared test kits on a timely basis.

Our products are also subject
to approval, certification and regulation by foreign regulatory and safety agencies. For example, the EU has adopted the EU MDR, which
imposes stricter requirements for the marketing and sale of medical devices, including in the area of clinical evaluation requirements,
quality systems and post-market surveillance. Complying with the requirements of the EU MDR may require us to incur significant expenditures.
Failure to meet these requirements could adversely impact our business in the EEA and other regions that tie their product registrations
to the EU requirements.

Once commercialized, modifications to our marketed
products may require new 510(k) clearances or approval of PMA supplements, or equivalent steps in other countries or regions including
the EEA, or may require us to cease marketing or recall the modified products until certification, clearances or regulatory approvals
are obtained.

Modifications to any of our products
once they are commercialized may require new regulatory approvals or clearances, including 510(k) clearances or approval of PMA supplements,
or require us to recall or cease marketing the modified systems until these clearances or approvals are obtained. The FDA requires device
manufacturers to initially make and document a determination of whether or not a modification requires a new approval, supplement or clearance.
A manufacturer may determine that a modification could not affect safety or efficacy and does not represent a major change in its intended
use, so that no new clearance or approval is necessary. However, the FDA can review a manufacturer’s decision and may disagree.
The FDA may also on its own initiative determine that a new clearance or approval of a PMA Supplement is required. We may make modifications
in the future that we believe do not or will not require additional clearances or approvals. If the FDA disagrees and requires new clearances
or approvals for the modifications, we may be required to recall and to stop marketing our products as modified, which could require us
to redesign our products and/or seek new marketing authorizations and harm our operating results. In these circumstances, we may be subject
to significant enforcement actions.

48

For example, if a manufacturer
determines that a modification to a PMA approved device could affect its safety or effectiveness or would constitute a major change in
its intended use, then the manufacturer must file for a new a new PMA or approval of a PMA supplement. Where we determine that modifications
to our products require a new PMA approval, we may not be able to obtain