Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 134

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 134
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 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.

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The FDA will approve the new
device for commercial distribution if it determines that the data and information in the PMA constitute valid scientific evidence and
that there is reasonable assurance that the device is safe and effective for its intended use(s). The FDA may approve a PMA with post-approval
conditions intended to ensure the safety and effectiveness of the device, including, among other things, restrictions on labeling, promotion,
sale and distribution, and collection of long-term follow-up data from patients in the clinical study that supported PMA approval or requirements
to conduct additional clinical studies post-approval. The FDA may condition PMA approval on some form of post-market surveillance when
deemed necessary to protect the public health or to provide additional safety and efficacy data for the device in a larger population
or for a longer period of use. In such cases, the manufacturer might be required to follow certain patient groups for a number of years
and to make periodic reports to the FDA on the clinical status of those patients. Failure to comply with the conditions of approval can
result in material adverse enforcement action, including withdrawal of the approval.

Certain changes to an approved
device, such as changes in manufacturing facilities, methods, or quality control procedures, or changes in the design performance specifications,
which affect the safety or effectiveness of the device, require submission of a PMA supplement. PMA supplements often require submission
of the same type of information as a PMA, except that the supplement is limited to information needed to support any changes from the
device covered by the original PMA and may not require as extensive clinical data or the convening of an advisory panel. Certain other
changes to an approved