Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 523

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 523
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 a de novo application, or PMA approval is obtained. Also, in these circumstances, the manufacturer may be
subject to significant regulatory fines or penalties.

PMA Approval Pathway. Class
III devices require approval of a PMA before they can be marketed, although some pre-amendment Class III devices for which the FDA has
not yet required a PMA are cleared through the 510(k) process. The PMA process is more demanding than the 510(k) premarket notification
process. In a PMA application, the manufacturer must demonstrate that the device is safe and effective, and the PMA application must be
supported by extensive data, including data from preclinical studies and human clinical trials. The PMA application must also contain
a full description of the device and its components, a full description of the methods, facilities, and controls used for manufacturing,
and proposed labeling. Following receipt of a PMA application, the FDA determines whether the application is sufficiently complete to
permit a substantive review. If the FDA accepts the application for review, it has 180 days under the FFDCA to complete its review of
a PMA application, although in practice, the FDA’s review often takes significantly longer, and can take up to several years. An
advisory panel of experts from outside the FDA may be convened to review and evaluate the application and provide recommendations to the
FDA as to the approvability of the device. The FDA may or may not accept the panel’s recommendation. In addition, the FDA will generally
conduct a pre-approval inspection of the applicant or its third-party manufacturers’ or suppliers’ manufacturing facility
or facilities to ensure compliance with the QSR. PMA devices are also subject to the payment of user fees.

The FDA will approve the new device
for commercial distribution if it determines that the data and information in the PMA application constitute valid scientific evidence
and that there is reasonable assurance that the device is safe and effective for its intended use(s). A PMA may include post-approval
conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion,
sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported the PMA or requirements
to conduct additional clinical studies post-approval. The FDA may condition PMA approval on some form of post-market surveillance when
deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a larger