Company: RGNT
Filing Date: 2025-09-30
Form Type: F-1/A
Source: 0001213900-25-093302
Chunk: 138

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-09-30
Form: F-1/A
Chunk 138
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 process;                                          |

| ● | labeling regulations and                                                                                               
 FDA prohibitions against the promotion of investigational 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 PMA approved devices that could significantly affect safety or effectiveness or that would constitute a 
 major change in intended use of one of our cleared devices, or approval of certain modifications to PMA-approved devices;        |

| ● | 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, if the malfunction were to recur;                                                                   |

| ● | 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; |

| ● | 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 the device.                                                                                        |

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. As a manufacturer, we are subject to periodic scheduled or unscheduled inspections by the FDA.
Failure to maintain compliance with the QSR requirements could result in the shut-down of, or restrictions on, manufacturing operations
and the recall or seizure of marketed products. The discovery of previously unknown problems with any marketed products, 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 clearance