Company: PETVW
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001641172-25-018617
Chunk: 15

Company: PetVivo Holdings, Inc.
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 15
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 commercial distribution.

In
the EU, medical devices are required to comply with the Medical Devices Directive and obtain CE Mark certification in order to market
medical devices. The CE Mark certification, granted following approval from an independent Notified Body, is an international symbol
of adherence to quality assurance standards and compliance with applicable European Medical Devices Directives. Distributors of medical
devices may also be required to comply with other foreign regulations such as Ministry of Health Labor and Welfare approval in Japan.
The time required to obtain these foreign approvals to market our products may be longer or shorter than that required in the U.S., and
requirements for those approvals may differ from those required by the FDA. In Europe, our devices are classified as Class IIa or IIb,
and will need to conform to the Medical Devices Regulation.

11

In
the U.S., specific permission from the FDA to distribute a new device is usually required (that is, other than in the case of very low-risk
devices), and we expect that some form of marketing authorization will be necessary for our devices. Marketing authorization is generally
sought and obtained in one of two ways. The first process requires that a pre-market notification (510(k) Submission) be made to the
FDA to demonstrate that the device is as safe and effective as, or “substantially equivalent” to, a legally-marketed device
that is not subject to pre-market approval (“PMA”). A legally-marketed device is a device that (i) was legally marketed prior
to May 28, 1976, (ii) has been reclassified from Class III to Class II or I, or (iii) has been found to be substantially equivalent to
another legally-marketed device following a 510(k) Submission. The legally-marketed device to which equivalence is drawn is known as
the “predicate” device. Applicants must submit descriptive data and, when necessary, performance data to establish that the
device is substantially equivalent to a predicate device. In some instances, data from human clinical studies must also be submitted
in support of a 510(k) Submission. If so, these data must be collected in a manner that conforms with specific requirements in accordance
with federal regulations including the Investigational Device Exemption (IDE) and human subjects protections or “Good Clinical
Practice” regulations. After the 510(k) application is submitted, the applicant cannot market the device unless FDA issues “510(k)
clearance” deeming the device substantially equivalent. After an applicant has obtained clearance