Company: ECIA
Filing Date: 2025-07-10
Form Type: 10-K
Source: 0001079973-25-001132
Chunk: 13

Company: ENCISION INC
Filing Date: 2025-07-10
Form: 10-K
Item: Item 1
Chunk 13
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 FDA regulates us and our products under a number of statutes, including the Federal Food, Drug, and Cosmetics
Act (the “FDC Act”). Under the FDC Act, medical devices are classified as Class I, II, or III based on the controls deemed
necessary to reasonably ensure their safety and effectiveness. Class I devices are subject to the least extensive controls, as their safety
and effectiveness can be reasonably assured through general controls (e.g., labeling, pre-market notification, and adherence to QSR).
For Class II devices, safety and effectiveness can be assured using special controls (e.g., performance standards, post-market surveillance,
patient registries, and FDA guidelines). Class III devices (e.g., life-sustaining or life-supporting implantable devices or new devices
which have been found not to be substantially equivalent to legally marketed devices) require the highest level of control, generally
requiring pre-market approval by the FDA to ensure their safety and effectiveness. Our products are Class II devices.

If a manufacturer or distributor of medical devices
can establish that a proposed device is "substantially equivalent" to a legally marketed Class I or Class II medical device
or to a Class III medical device for which the FDA has not required a pre-market approval application, the manufacturer or distributor
may seek FDA marketing clearance for the device by filing a 510(k) pre-market notification. Following submission of the 510(k) notification,
the manufacturer or distributor may not place the device into commercial distribution in the United States until an order has been issued
by the FDA. The FDA's target for issuing such orders is within 90 days of submission, but the process can take significantly longer. The
order may declare the FDA's determination that the device is "substantially equivalent" to another legally marketed device and
allow the proposed device to be marketed in the United States. The FDA may, however, determine that the proposed device is not substantially
equivalent or may require further information, such as additional test data, before deciding regarding substantial equivalence. Any adverse
determination or request for additional information could delay market introduction and have a material adverse effect on our continued
operations. We have received a favorable 510(k) notification for our AEM monitors and AEM Instruments, all of which are designated as
Class II medical devices.

Labeling and promotional activities are subject
to scrutiny by the FDA and, in certain instances, by the Federal Trade Commission. The FDA also imposes post-marketing controls on us
and our