Company: RGNT
Filing Date: 2025-02-12
Form Type: DRS/A
Source: 0001213900-25-012299
Chunk: 134

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-02-12
Form: DRS/A
Chunk 134
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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.

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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