Company: PETVW
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001641172-25-018617
Chunk: 16

Company: PetVivo Holdings, Inc.
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 16
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, the changes to existing devices
covered by a 510(k) Submission that do not significantly affect safety or effectiveness can generally be made without additional 510(k)
Submissions, but evaluation of whether a new 510(k) is needed is a complex regulatory issue, and changes must be evaluated on an ongoing
basis to determine whether a proposed change triggers the need for a new 510(k), or even PMA. The 510(k) clearance pathway is not available
for all devices: whether it is a suitable path to market depends on several factors, including regulatory classifications, the intended
use of the device, and technical and risk-related issues for the device.

The
second, more rigorous, process requires that an application for PMA be made to the FDA to demonstrate that the device is safe and effective
for its intended use as manufactured. This approval process applies to most Class III devices. A PMA submission includes data regarding
design, materials, bench and animal testing, and human clinical data for the medical device. Again, clinical trials are subject to extensive
FDA regulation. Following completion of clinical trials and submission of a PMA, the FDA will authorize commercial distribution if it
determines there is reasonable assurance that the medical device is safe and effective for its intended purpose. This determination is
based on the benefit outweighing the risk for the population intended to be treated with the device. This process is much more detailed,
time-consuming, and expensive than the 510(k) process. Also, FDA may impose a variety of conditions on the approval of a PMA.

Both
before and after a device for the U.S. market is commercially released, we would have ongoing responsibilities under FDA regulations.
The FDA reviews design and manufacturing practices, labeling and record keeping, and manufacturers’ required reports of adverse
experiences and other information to identify potential problems with marketed medical devices. We would also be subject to periodic
inspection by the FDA for compliance with the FDA’s quality system regulations, which govern the methods used in, and the facilities
and controls used for, the design, manufacture, packaging, and servicing of all finished medical devices intended for human use. In addition,
the FDA and other U.S. regulatory bodies (including the Federal Trade Commission, the Office of the Inspector General of the Department
of Health and Human Services, the Department of Justice (DOJ), and various state Attorneys General) monitor the manner in which we promote
and advertise our products. Although physicians are permitted to use their medical judgment to