Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 144

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 144
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 been reclassified from Class III to Class II or I, or a device that was found substantially equivalent through the 510(k) process.
The FDA’s 510(k) clearance process usually takes nine to 12 months, but may take significantly longer. The FDA may require additional
information, including clinical data, to make a determination regarding substantial equivalence. If the FDA agrees that the device is
substantially equivalent to a predicate device currently on the market, it will grant 510(k) clearance to commercially market the device.
If the FDA determines that the device is “not substantially equivalent” to a previously cleared device, the device is automatically
designated as a Class III device. The device sponsor must then fulfill more rigorous PMA requirements, or can request a risk-based classification
determination for the device in accordance with the de novoclassification process, which is a route to market for novel medical
devices that are low to moderate risk and are not substantially equivalent to a predicate device.

Premarket Approval Process

A PMA application must be submitted
if the medical device is in Class III (although the FDA has the discretion to continue to allow certain pre-amendment Class III devices
to use the 510(k) process) or cannot be cleared through the 510(k) process. A PMA application must be supported by, among other things,
extensive technical, pre-clinical, clinical trials, manufacturing, and labeling data to demonstrate to the FDA’s satisfaction the
safety and effectiveness of the device.

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After a PMA application is submitted and filed, the
FDA begins an in-depth review of the submitted information, which typically takes between one and three years, but may take significantly
longer. During this review period, the FDA may request additional information or clarification of information already provided. Also,
during the review period, an advisory panel of experts from outside the FDA will usually be convened to review and evaluate the application
and provide recommendations to the FDA as to the approvability of the device. In addition, the FDA will conduct a pre-approval inspection
of the manufacturing facility to ensure compliance with the QSR, which imposes extensive design development, testing, control, documentation
and other quality assurance procedures in the design and manufacturing process. The FDA may approve a PMA application with post-approval
conditions intended to ensure the safety and effectiveness of the device including, among other things, restrictions on labeling, promotion,
sale, distribution, and collection of long-term follow-up