Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 530

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 530
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arketing Safety Reporting, which is intended to assist manufacturers of combination products comply
with reporting requirements applicable to such products.

After issuing marketing authorizations,
the FDA has discretion in determining post-approval compliance requirements for combination products. The FDA has also promulgated regulations
pertaining to compliance with certain current good manufacturing practices (“cGMP”) requirements for drug components as well
as QSR requirements for device constituents of a combination product. Other post-market requirements in the same vein as those described
above for medical devices and drugs will also apply, depending on the application type and center overseeing regulation of the combination
product, including:

    ●
    Other record-keeping requirements;

    ●
    Post-market adverse event and Medical Device Reporting requirements;

    ●
    Labelling regulations and FDA prohibitions against the promotion of products for uncleared, unapproved or off-label uses;

    ●
    Advertising and promotion requirements;

    ●
    Restrictions on sale, distribution or use of the product;

    ●
    Requirements for recalls being conducted and recall reporting;

    ●
    An order of repair, replacement or refund;

    ●
    Product tracking requirements; and

    ●
    Post-market surveillance or clinical trials.

25

Coverage and Reimbursement.
Coverage and reimbursement for medical devices in the U.S. is determined by third-party payors, including Medicare and Medicaid, commercial
health insurers, and managed care organizations. Each payor has a unique process for determining whether to cover a device for a particular
indication and how to set reimbursement rates for the device. A payor can decide to cover a device yet not provide adequate reimbursement
to ensure access to the device. New devices often face significant uncertainty about coverage and reimbursement. Payors may require additional
evidence, beyond the data required for FDA approval, to demonstrate that a device should be covered for a particular indication or that
it should be reimbursed at a higher rate than other technologies. In addition, health care spending continues to be a concern for federal
and state governments, as well as for commercial payors. Governments continue to debate methods of controlling health care costs, including
reductions in reimbursement or additional controls on utilization of new technologies in Medicare and Medicaid, and commercial payors
may similarly seek to limit spending on new devices. Restrictions on coverage and reimbursement could harm our future revenues and ability
to realize an appropriate return on our investment.

Orphan Drug Designation and
Exclusivity. Under the Orphan Drug Act, the