Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 162

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 162
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 to extensive regulation by the U. S. Food and Drug Administration, or FDA, and other federal and state authorities in the United
States, as well as comparable authorities in foreign jurisdictions. Our product candidates are subject to regulation as medical devices
in the United States under the Federal Food, Drug, and Cosmetic Act, or FDCA, as implemented and enforced by the FDA.

United States Regulation of Medical Devices

The FDA regulates the development,
design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging, storage, installation, servicing, recordkeeping,
premarket clearance or approval, adverse event reporting, advertising, promotion, marketing and distribution, and import and export of
medical devices to ensure that medical devices distributed domestically are safe and effective for their intended uses and otherwise meet
the requirements of the FDCA.

FDA premarket clearance and approval
requirements

Unless an exemption applies,
each medical device commercially distributed in the United States requires either FDA clearance of a 510(k) premarket notification, or
approval of a premarket approval, or PMA, application. Under the FDCA, medical devices are classified into one of three classes-Class
I, Class II or Class III-depending on the degree of risk associated with each medical device and the extent of manufacturer and regulatory
control needed to ensure its safety and effectiveness. Class I includes devices with the lowest risk to the patient and are those for
which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance
with the applicable portions of the Quality System Regulation, or QSR, facility registration and product listing, reporting of adverse
medical events, and truthful and non-misleading labeling, advertising, and promotional materials. Class II devices are subject to the
FDA’s General Controls, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device.
These special controls can include performance standards, post-market surveillance, patient registries and FDA guidance documents.

While most Class I devices
are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA
a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device. The FDA’s
permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance. Devices
deemed by the FDA to pose the greatest risks, such as life-sustaining,