Company: PETVW
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001641172-25-018617
Chunk: 17

Company: PetVivo Holdings, Inc.
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 17
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 employ medical devices for indications
other than those cleared or approved by the FDA, we are prohibited from promoting products for such “off-label” uses and
can only market our products for cleared or approved uses. If the FDA were to conclude that we are not in compliance with applicable
laws or regulations, or that any of our medical devices are ineffective or pose an unreasonable health risk, the FDA could require us
to notify health professionals and others that the devices present unreasonable risks of substantial harm to the public health, order
a recall, repair, replacement, or refund of such devices, detain or seize adulterated or misbranded medical devices, or ban such medical
devices. The FDA may also impose operating restrictions, enjoin and/or restrain certain conduct resulting in violations of applicable
law pertaining to medical devices, including a hold on approving new devices until issues are resolved to its satisfaction, and assess
civil or criminal penalties against our officers, employees, or us. The FDA may also recommend prosecution to the DOJ. Conduct giving
rise to civil or criminal penalties may also form the basis for private civil litigation by third-party payers or other persons allegedly
harmed by our conduct.

12

The
delivery of our devices in the U.S. market would be subject to regulation by the U.S. Department of Health and Human Services and comparable
state agencies responsible for reimbursement and regulation of healthcare items and services. U.S. laws and regulations are imposed primarily
in connection with the Medicare and Medicaid programs, as well as the government’s interest in regulating the quality and cost
of health care.

Federal
healthcare laws apply when we or customers submit claims for items or services that are reimbursed under Medicare, Medicaid, or other
federally-funded healthcare programs. The principal federal laws include: (1) the False Claims Act which prohibits the submission of
false or otherwise improper claims for payment to a federally-funded health care program; (2) the Anti-Kickback Statute which prohibits
offers to pay or receive remuneration of any kind for the purpose of inducing or rewarding referrals of items or services reimbursable
by a Federal health care program; (3) the Stark law which prohibits physicians from referring Medicare or Medicaid patients to a provider
that bills these programs for the provision of certain designated health services if the physician (or a member of the physician’s
immediate family) has a financial relationship with that provider; and (4) health care fraud statutes that prohibit false statements
and improper claims to any