Company: RGNT
Filing Date: 2025-03-11
Form Type: F-1
Source: 0001213900-25-022350
Chunk: 133

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-03-11
Form: F-1
Chunk 133
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 advertising, promotion, marketing and distribution, and import and export of
medical devices to ensure that medical devices distributed domestically are safe and effective for their intended uses and otherwise
meet the requirements of the FDCA.

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FDA Premarket Clearance and Approval Requirements

Unless an exemption applies,
each medical device commercially distributed in the United States requires either FDA clearance of a 510(k) premarket notification, or
approval of a PMA. Under the FDCA, medical devices are classified into one of three classes—Class I, Class II or Class III—depending
on the degree of risk associated with each medical device and the extent of manufacturer and regulatory control needed to ensure its
safety and effectiveness. Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness
can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions
of the QSR, facility registration and product listing, reporting of adverse medical events, and truthful and non-misleading labeling,
advertising, and promotional materials. Class II devices are subject to the FDA’s General Controls, and special controls as
deemed necessary by the FDA to ensure the safety and effectiveness of the device. These special controls can include performance standards,
post-market surveillance, patient registries and FDA guidance documents.

While most Class I devices
are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to
the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device. The
FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance.
Devices deemed by the FDA to pose the greatest risks, such as life sustaining, life supporting or some implantable devices, or devices
that have a new intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are
placed in Class III, requiring approval of a PMA. Some pre-amendment devices are unclassified, but are subject to FDA’s premarket
notification and clearance process in order to be commercially distributed. We are in the process of pursuing approval of one of our
product candidates under a PMA.

510(k) Clearance Marketing Pathway

To obtain 510(k) clearance,
an applicant must submit to the FDA a premarket notification submission demonstrating that the proposed device is “