Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 147

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 147
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 manufacturer to determine whether the proposed change requires submission of a 510(k)
or a PMA in the first instance, but the FDA can review any such decision and disagree with a manufacturer’s determination. Many
minor modifications today are accomplished by a manufacturer documenting the change in an internal letter-to-file. The letter-to-file
is in lieu of submitting a new 510(k) to obtain clearance for every change. The FDA can always review these letters to file in an inspection.
If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to cease marketing and/or request
the recall of the modified device until 510(k) marketing clearance or PMA is obtained. Also, in these circumstances, the manufacturer
may be subject to significant regulatory fines or penalties.

Post-market Regulation

After a device is cleared or approved for marketing,
numerous and extensive regulatory requirements continue to apply. These include:

  establishment registration and device listing with the FDA;  

  QSR requirements, which require manufacturers, including third-party manufacturers,                                                    

  labeling and marketing regulations, which require that promotion is truthful, not misleading,                                                

  FDA guidance on off-label dissemination of information and responding to unsolicited  

  clearance or approval of product modifications to 510(k)-cleared devices that could                                             
  significantly affect safety or efficacy or that would constitute a major change in intended use of one of our cleared devices;  
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  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 malfunctioned and the device or a similar  
  device that it markets would be likely to cause or contribute to a death or serious injury or serious adverse events, if the malfunction      
  were to recur;                                                                                                                                
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  85  

  correction, removal and recall reporting regulations, which require that manufacturers                                                  
  report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to  
  remedy a violation of the FDCA that may present a risk to health;                                                                       
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  complying with regulations requiring Unique Device Identifiers (UDI) on devices and