Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 133

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 133
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 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 novo classification.
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 PMA, the manufacturer must demonstrate that the device is safe and effective, and the PMA must be supported by
extensive data, including data from preclinical studies and human clinical trials. The PMA must also contain a full description of
the device and its components, a full description of the methods, facilities, and controls used for manufacturing, and proposed
labeling. Following receipt of a PMA, the FDA determines whether the application is sufficiently complete to permit a substantive
review. If FDA accepts the