Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 137

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 137
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 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 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