Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 40

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 40
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require that we conduct one or more clinical studies to demonstrate that the device is safe and effective. In some cases, such studies
may be requested for a 510(k) as well. We may not be able to meet the requirements to obtain 510(k) clearance or PMA approval (or a de
novoclassification request), in which case the FDA may not grant any necessary clearances or approvals. In addition, the FDA may
place significant limitations upon the intended uses of our products as a condition to a 510(k) clearance, PMA approval or de novoclassification. Product applications can also be denied or withdrawn due to failure to comply with regulatory requirements or the occurrence
of unforeseen problems following clearance or approval. Any delays or failure to obtain FDA clearance or approval of new products we develop,
any limitations imposed by the FDA on new product use or the costs of obtaining FDA clearance or approvals could have a material adverse
effect on our business, financial condition, and results of operations.

Even if granted, a 510(k) clearance, de novoclassification,
or PMA imposes substantial restrictions on how our devices may be marketed or sold, and the FDA continues to place considerable restrictions
on our products and operations. For example, the manufacture of medical devices must comply with the FDA’s Quality System Regulation
(QSR). In addition, manufacturers must register their manufacturing facilities, list their products with the FDA, and comply with requirements
relating to labeling, marketing, complaint handling, adverse event and medical device reporting, reporting of corrections and removals,
and import and export restrictions. The FDA monitors compliance with the QSR and these other requirements through periodic inspections.
If our facilities or those of our suppliers are found to be in violation of applicable laws and regulations, or if we or suppliers fail
to take satisfactory corrective action in response to an adverse inspection, the regulatory authority could take enforcement action, including
any of the following sanctions: untitled letters, warning letters, fines, injunctions, consent decrees, and civil penalties; customer
notifications or repair, replacement, refunds, recalls, detention or seizure of our products; operating restrictions or partial suspension
or total shutdown of production; refusing or delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified
products; withdrawing 510(k) marketing clearances, PMA approvals and/or de novoclassifications that have already been granted;
refusing to provide Certificates for Foreign Government; refusing to grant export approval