Company: RGNT
Filing Date: 2025-01-27
Form Type: DRS/A
Source: 0001213900-25-006676
Chunk: 135

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-27
Form: DRS/A
Chunk 135
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 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
receipt by the FDA unless the FDA notifies the company that the investigation may not begin. If the FDA determines that there are deficiencies
or other concerns with an IDE for which it requires modification, the FDA may permit a clinical trial to proceed under a conditional approval.

Regardless of the degree of
risk presented by the medical device, clinical studies must be approved by, and conducted under the oversight of, an Institutional Review
Board, or IRB, for each clinical site. The IRB is responsible