Company: RGNT
Filing Date: 2025-10-24
Form Type: F-1/A
Source: 0001213900-25-101900
Chunk: 136

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-10-24
Form: F-1/A
Chunk 136
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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 device require the submission of a new PMA, such as when the design change causes a different intended use, mode
of operation, and technical basis of operation, or when the design change is so significant that a new generation of the device will
be developed, and the data that were submitted with the original PMA are not applicable for the change in demonstrating a reasonable
assurance of safety and effectiveness. FDA may not approve a modification described in a PMA supplement, in which case the modified device
cannot be marketed.

Clinical Trials

Clinical trials are almost
always required to support a PMA and are sometimes required to support a 510(k) submission. All clinical investigations of devices to
determine safety and effectiveness must be conducted in accordance with the FDA’s IDE regulations which govern investigational
device