Company: PETVW
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001641172-25-018617
Chunk: 18

Company: PetVivo Holdings, Inc.
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 18
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 third-party payer. There are often similar state false claims, anti-kickback, and anti-self-referral and insurance
laws that apply to state-funded Medicaid and other health care programs and private third-party payers. In addition, the U.S. Foreign
Corrupt Practices Act can be used to prosecute companies in the U.S. for arrangements with physicians, or other parties outside the U.S.
if the physician or party is a government official of another country and the arrangement violates the law of that country.

The
laws applicable to us are subject to change, and subject to evolving interpretations. If a governmental authority were to conclude that
we are not in compliance with applicable laws and regulations, we and our officers and employees could be subject to severe criminal
and civil penalties including substantial fines and damages, and exclusion from participation as a supplier of product to beneficiaries
covered by Medicare or Medicaid.

The
process of obtaining clearance to market products is costly and time-consuming in virtually all of the major markets in which we expect
to sell products and may delay the marketing and sale of our products. Countries around the world have recently adopted more stringent
regulatory requirements, which are expected to add to the delays and uncertainties associated with new product releases, as well as the
clinical and regulatory costs of supporting those releases. No assurance can be given that any of our other medical devices will be approved
on a timely basis, if at all. In addition, regulations regarding the development, manufacture, and sale of medical devices are subject
to future change. We cannot predict what impact, if any, those changes might have on our business. Failure to comply with regulatory
requirements could have a material adverse effect on our business, financial condition, and results of operations.

Pertaining
to our Spryng® product (offered for veterinary use only), in the U.S., the FDA does not require submission of a 510(k), PMA, or any
pre-market approval for devices used in veterinary medicine. Device manufacturers who exclusively manufacture or distribute veterinary
devices are not required to register their establishments and list veterinary devices and are exempt from post-marketing reporting. The
FDA does have regulatory oversight over veterinary devices and can take appropriate regulatory action if a veterinary device is misbranded
or adulterated. It is the responsibility of the manufacturer and/or distributor of these articles to assure that these animal devices
are safe, effective, and properly labeled.

Exported
devices are subject to the regulatory requirements of each country to which the device is