Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 145

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 145
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 data from patients in the clinical study that supported approval. Failure to
comply with the conditions of approval can result in materially adverse enforcement action, including the loss or withdrawal of the approval.
New PMA applications or supplements are required for significant modifications to the manufacturing process, labeling of the product and
design of a device that is approved through the PMA process. PMA supplements often require submission of the same type of information
as an original PMA application, except that the supplement is limited to information needed to support any changes from the device covered
by the original PMA application, and may not require as extensive clinical data or the convening of an advisory panel.

De novo Classification Process

Medical device types that the FDA has not previously
classified as Class I, II, or III are automatically classified as Class III regardless of the level of risk they pose. The Food and Drug
Administration Modernization Act of 1997 established a new route to market for low to moderate risk medical devices that are automatically
placed into Class III due to the absence of a substantially equivalent predicate device, called the “ Request for Evaluation of Automatic
Class III Designation,” or the de novoclassification process. This process allows a manufacturer whose novel device is automatically
classified as Class III to request down-classification of its medical device into Class I or Class II on the basis that the device presents
low or moderate risk, rather than requiring the submission and approval of a PMA application. Prior to the enactment of the Food and Drug
Administration Safety and Innovation Act, or FDASIA, in July 2012, a medical device could only be eligible for de novoclassification
if the manufacturer first submitted a 510(k) premarket notification and received a determination from the FDA that the device was not
substantially equivalent to a predicate device. The FDASIA streamlined the de novoclassification pathway by permitting manufacturers
to request de novoclassification directly without first submitting a 510(k) premarket notification to the FDA and receiving a
“not substantially equivalent” determination. We obtained marketing authorization for the OCD indication for our Deep TMS
system using the direct de novorequest classification process. We have used the 510(k) clearance process to obtain authorization
from the FDA for changes to our marketed Deep TMS system, including applications extending our clearances to our proprietary stimulator,
and expansions to our MDD indication which now allow us to market a shorter 3 minute depression protocol as well the ability to