Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 43

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 43
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MA. Modifications to products that have been approved
through the PMA process generally require premarket FDA approval. Similarly, certain modifications made to products cleared through a
510(k) or authorized through the de novoclassification process may require a new 510(k) clearance. Each of the PMA, de novoclassification and the 510(k) clearance processes can be expensive, lengthy, and uncertain. The FDA’s 510(k) clearance process usually
takes from three to 12 months, but can be longer. The process of obtaining a PMA is much more costly and uncertain than the 510(k) clearance
process and generally takes from one to three years, or even longer, from the time the application is filed with the FDA. In addition,
a PMA generally requires the performance of one or more clinical trials. The de novoprocess generally takes between 4 months and
one year.

Despite the time, effort and cost invested by us
in an FDA approval or clearance process, a device may eventually not be approved or cleared by the FDA. Any delay or failure to obtain
necessary regulatory authorizations could harm our business. Furthermore, even if we are granted regulatory authorizations, they may include
significant limitations on the indicated uses for the device, which may limit the market for the device.

Any modifications to our existing products may require
new 510(k) clearance; however, future modifications may be subject to the substantially more costly, time-consuming, and uncertain PMA
process. If the FDA requires us to go through a lengthier, more rigorous examination for future products or modifications to existing
products than we had expected, product introductions or modifications could be delayed or canceled, which could cause our sales to decline
and our expenses to increase.

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The FDA requires every manufacturer to make the modification
determination in the first instance, but the FDA may review any manufacturer’s decision. The FDA may not agree with our decisions
regarding whether new authorizations are necessary. We made modifications to our products in the past and have determined based on our
review of the applicable FDA regulations and guidance that in certain instances new 510(k) clearances were not required. We may make modifications
or add additional enhancements or features in the future that we believe do not require a new 510(k) clearance, de novoclassification
or a PMA. If the FDA disagrees with our determination and requires us to submit new 510(k) notifications, de novoclass