Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 169

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 169
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ational products, or the promotion of “off-label” uses of cleared or approved products;                                    
  requirements related to promotional activities;                                                                                                                                                       
  clearance or approval of product modifications to cleared devices or devices authorized through the de novo classification process that could significantly affect safety or effectiveness, or th...  
  medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctione...  
  correction, removal and recall reporting                                                                                                                                                              
  complying with the laws and regulations requiring Unique Device Identifiers on devices and also requiring the submission of certain information about each device to the FDA’s Global Unique Devi...  
  the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations; and                         
  post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for t...  

Manufacturing processes for
medical devices are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls
for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation
and servicing of finished devices intended for human use. The QSR also requires, among other things, maintenance of a device master file,
device history file, and complaint files. Medical device manufacturers are subject to periodic scheduled or unscheduled inspections by
the FDA. Failure to maintain compliance with the QSR requirements could result in the shutdown of, or restrictions on, manufacturing operations
and the recall or seizure of marketed products. The discovery of previously unknown problems with marketed medical devices, including
unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within
the scope of its marketing authorization or off-label by a physician in the practice of medicine, could result in restrictions on the
device, including the removal of the product from the market or voluntary or mandatory device recalls.

The FDA has broad regulatory
compliance and enforcement powers. If the FDA determines that a manufacturer has failed to comply with applicable regulatory requirements,
it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:

  warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties;      
  recalls, withdrawals, or administrative detention or product seizures;                           
  operating