Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 38

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 38
---

of products into the market; total or partial suspension of production; refusal to grant future clearances or approvals; withdrawals or
suspensions of current clearances or approvals, resulting in prohibitions on sales of our products; and in the most serious cases, criminal
penalties.

An element of our strategy is to continue to upgrade
our Deep TMS systems, add new enhancements and features, pursue next-generation equipment versions utilizing our patented technology,
expand clearance or approval of the Deep TMS System to include new indications or broader application and introduce different treatment
plans. In the United States, before we can market a new medical device, claim new or expanded indications for use or introduce a significant
modification to an existing product, or implement new treatment plans, we must first receive either clearance under Section 510(k) of
the Federal Food, Drug, and Cosmetic Act, or the FDCA, premarket approval application (PMA) or de novoclassification, from the
FDA, unless an exemption applies. In the PMA process, the FDA must determine that a proposed device is safe and effective for its intended
use based, in part, on extensive data, including, but not limited to, technical, pre-clinical, clinical trial, manufacturing, and labeling
data. The PMA process is typically required for devices that are deemed to pose the greatest risk, such as life-sustaining, life-supporting
or implantable devices. However, some devices are automatically subject to the PMA pathway regardless of the level of risk they pose because
they have not previously been classified into a lower risk class by the FDA. Manufacturers of these devices may request that FDA review
such devices in accordance with the de novoclassification procedure, which allows a manufacturer whose novel device would otherwise
require a PMA prior to marketing to request down-classification of the device on the basis that the device presents low or moderate risk.
If the FDA grants the de novoclassification request, the applicant will then receive authorization to market the device. This
device type can then be used as a predicate device for future 510(k) submissions. In the 510(k) clearance process, before a device may
be marketed, the FDA must determine that a proposed device is “substantially equivalent” to a legally-marketed “predicate”
device, which includes a device that has been previously cleared through the 510(k) process, a device that was legally marketed prior
to May 28, 1976