Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 132

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 132
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 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 “substantially
equivalent” to a legally marketed predicate device. A predicate device is a legally marketed device that is not subject to premarket
approval, i.e., a device that was legally marketed before May 28, 1976 (pre-amendments device) and for which a PMA is not required,
a device that has been reclassified from Class III to Class II or I, or a device that was found substantially equivalent through
the 510(k) process. The FDA’s 510(k) clearance process usually takes from three to twelve months, but may take longer. The FDA may
require additional information, including clinical data,