Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 135

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 135
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 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 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 application for
review, it has 180 days under the FDCA to complete its review of a PMA, although in practice, the FDA’s review often takes significantly
longer, and can take up to several years. An advisory panel of experts from outside the FDA may be convened to review and evaluate the
application and provide recommendations to the FDA as to the approvability of the device. The FDA may or may not accept the panel’s
recommendation. In addition, the FDA will generally conduct a pre-approval inspection of the applicant or its third-party manufacturers’
or suppliers’ manufacturing facility or facilities to ensure compliance with the QSR. PMA applications are also subject to the
payment of user fees, which for fiscal year 2024 includes a standard application fee of $483,560