Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 165

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 165
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 effectiveness of the device, including, among other things, restrictions on labeling, promotion,
sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported PMA approval or requirements
to conduct additional clinical studies post-approval. The FDA may condition PMA approval on some form of post-market surveillance when
deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a larger population
or for a longer period of use. In such cases, the manufacturer might be required to follow certain patient groups for a number of years
and to make periodic reports to the FDA on the clinical status of those patients. Failure to comply with the conditions of approval can
result in material adverse enforcement action, including withdrawal of the approval.

Certain changes to an approved
device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the design performance specifications,
which affect the safety or effectiveness of the device, require submission of a PMA supplement. PMA supplements often require submission
of the same type of information as a PMA, except that the supplement is limited to information needed to support any changes from the
device covered by the original PMA and may not require as extensive clinical data or the convening of an advisory panel. Certain other
changes to an approved device require the submission of a new PMA, such as when the design change causes a different intended use, mode
of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will be
developed, and the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable assurance
of safety and effectiveness.

De novo classification process

Medical device types that
the FDA has not previously classified as Class I, II, or III are automatically classified into Class III regardless of the level of risk
they pose. The Food and Drug Administration Modernization Act of 1997 established a route to market for low-to-moderate risk medical devices
that are automatically placed into Class III due to the absence of a predicate device, called the “ Request for Evaluation of Automatic
Class III Designation,” or the de novoclassification procedure. This procedure allows a manufacturer whose novel device
is automatically classified into 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