Company: RGNT
Filing Date: 2025-07-07
Form Type: F-1/A
Source: 0001213900-25-061821
Chunk: 136

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-07-07
Form: F-1/A
Chunk 136
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 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 labeling, prohibit promotion of the investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities
of study sponsors and study investigators. If the device presents a “significant risk,” to human health, as defined by the
FDA, the FDA requires the device sponsor to submit an IDE application to the FDA, which must become effective before commencing human
clinical trials. If the device under evaluation does not present a significant risk to human health, then the device sponsor is not required
to submit an IDE application to the FDA before initiating human clinical trials, but must still comply with abbreviated IDE requirements
when conducting such trials. A significant risk device is one that presents a potential for serious risk to the health, safety or welfare
of a patient and either is implanted, used in supporting or sustaining human life, substantially important in diagnosing, curing, mitigating
or treating disease or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a subject.
An IDE application must be supported by appropriate data, such as animal and laboratory test results, showing that it is safe to test
the device in humans and that the testing protocol is scientifically sound. The IDE will automatically become effective 30 days after