Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 134

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 134
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market
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, to make a determination regarding substantial equivalence. In addition,
FDA collects user fees for certain medical device submissions and annual fees for medical device establishments.

If the FDA agrees that the
device is substantially equivalent to a predicate device currently on the market, it will grant 510(k) clearance to commercially market
the device. If the FDA determines that the device is “not substantially equivalent” to a previously cleared device, the device
is automatically designated as a Class III device. The device sponsor must then fulfill more rigorous PMA requirements, or can request
a risk-based classification determination for the device in accordance with the “de novo” process, which is a route
to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate device.

After a device receives 510(k)
clearance, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change or modification
in its intended use, will require a new 510(k) clearance or, depending on the modification, PMA approval or de novoclassification.
The FDA requires each manufacturer to determine whether the proposed change requires submission of a 510(k), de novo classification
or a PMA in the first instance, but the FDA can review any such decision and disagree with a manufacturer’s determination. 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, approval of a PMA, or issuance of a de novo classification. Also, in
these circumstances, the manufacturer may be subject to significant regulatory fines or penalties.

PMA Approval Pathway

Class III devices require
PMA approval before they can be marketed, although some pre-amendment Class III devices for which FDA has not yet required a PMA
are cleared through the 510(k) process. The PMA process is more demanding than the 510(k) premarket notification process. In a P