Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 394

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 394
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Other Regions

Most major markets have different levels of regulatory requirements for medical devices. Modifications to the approved or certified products may require a new regulatory submission in all major markets. The regulatory requirements, and the review time, vary significantly from country to country. Products can also be marketed in other countries that have minimal requirements for medical devices.

Drug-Device Combination Product Regulation

In the United States, products composed of components that would normally be regulated under different types of regulatory authorities, and frequently by different centers at the FDA, are known as combination products. In the case of Reflow RVO TM, if marketed individually, the ultrasound device would be regulated by FDA as a medical device while the microsphere component would be regulated by the

FDA as a drug. However, under the FDCA, the FDA is charged with assigning a center with primary jurisdiction, or a lead center, for review of a combination product. The designation of a lead center generally obviates the need for separate approval of each component of a combination product. The determination

of which center will be the lead center is based on the “primary mode of action” of the combination product. Thus, if the primary mode of action of a drug/device combination product is attributable to the device product, the FDA center responsible for pre-market review of the device product would have primary jurisdiction for the combination product. A combination product with a medical-device primary mode of action generally would be reviewed and approved pursuant to the medical device approval pathways set forth under the FDCA. In reviewing the marketing application for such a product, however, FDA reviewers in

the device center could consult with their counterparts in the drug center to ensure that the drug component of the combination product meets applicable requirements regarding safety and effectiveness. In addition, under FDA regulations, drug/device combination products are subject to cGMP requirements applicable to both drugs and devices, including the QSR applicable to medical devices.

Our Reflow RVO TMtreatment incorporates microspheres and ultrasound, or a drug and a device. As a result, it is likely that the regulatory review by FDA may involve the Office of Combination Products. Since the primary mechanism of action is generated through the acoustic energy from ultrasound, we anticipate that the FDA will assign the Center for Devices and Radiological Health as the lead review division for the regulatory submissions. Further, we anticipate that the submission will involve a PMA Application for the medical device.

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Drug and Biologics Regulation

In the United States, the FDA regulates drugs and biological products, under the FD