Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 380

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 380
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 approve or clear pending PMA, de novo, or 510(k) applications, withdrawal of an approval or clearance, imposition of a clinical hold, issuance of warning or untitled letters, product recalls, total or partial suspension of production or distribution, fines, refusals of government contracts, disgorgement of profits, import detentions, civil monetary penalties, product seizures, injunctions and civil or criminal investigations and penalties brought by the FDA and the Department of Justice (“DOJ”) or other governmental entities.

FDA’s Approval Requirements

Unless an exemption applies, each medical device commercially distributed in the United States will require either FDA clearance of a 510(k) pre-market notification, approval of a de novo application or approval of a PMA application. We anticipate that our LBI-201 Aureva TMPulse product candidate will be regulated as a Class III medical device and will require submission of a PMA application. Further, we anticipate that the LBI-001 Reflow RVO TMproduct candidate will also require submission of a PMA application, in addition to an NDA.

FDA Premarket Clearance and Approval Requirements

Under the FDCA, medical devices are classified into one of three classes — Class I, Class II or Class III — depending on the degree of risk associated with each medical device and the extent of manufacturing and regulatory control needed to provide reasonable assurance of safety and effectiveness.

Class I devices are deemed to be low risk and are those for which safety and effectiveness can be assured by adherence to the FDA’s General Controls for medical devices, which include compliance with the applicable portions of the Quality System Regulation (“QSR”), facility registration and product listing, reporting of adverse medical events and truthful and non-misleading labeling, advertising and promotion.

Most Class I devices are classified as exempt from the 510(k) premarket notification requirements and therefore may be commercially distributed without obtaining prior authorization from the FDA. Class II devices are subject to the FDA’s General Controls, and special controls as deemed necessary by the FDA to provide reasonable assurance of the safety and effectiveness of the device. Special controls can include performance standards, post-market surveillance, patient registries and FDA guidance documents.

Manufacturers of most Class II devices are required to submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device. The FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance. Devices deemed by the FDA to pose the greatest risks,