Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 387

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 387
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 offers significant advantages over existing approved or cleared devices, or (iv) the availability of the device is in the best interest of patients. Breakthrough Device designation provides certain benefits to device developers, including more interactive and timely communications with FDA staff, use of post-market data collection, when scientifically appropriate, to facilitate expedited and efficient development and review of the device, opportunities for efficient and flexible clinical study design, and prioritized review of premarket submissions. There is no guarantee that our LBI-002 biosynthetic cornea, LBI-201 Aureva TMPulse and LBI-001 Reflow RVO TMproduct candidates would qualify for Breakthrough Device designation.

Post-market Regulation by the FDA

Even after a device receives clearance or approval and is placed on the market, numerous regulatory requirements continue to apply. These include:

| ● | establishment                    
 registration and device listing; |

| ● | QSR                                                                                                                                          
 requirements, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation 
 and other quality assurance procedures during all aspects of the manufacturing process;                                                      |

| ● | labeling                                                                                                                               
 regulations, which require that promotion is truthful, not misleading, fairly balanced, provides adequate directions for use, and that 
 all claims are substantiated, and the FDA prohibitions against the promotion of products for uncleared, unapproved or “off-label”      
 uses and other requirements related to promotional activities;                                                                         |

| ● | clearance                                                                                                                              
 or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would   
 constitute a major change in intended use of one of our cleared devices, or approval of certain modifications to PMA-approved devices; |

| ● | medical                                                                                                                              
 device reporting regulations, which require that manufacturers report to the FDA if their device may have caused or contributed to   
 a death or serious injury, or if their device malfunctioned and the device or a similar device marketed by the manufacturer would be 
 likely to cause or contribute to a death or serious injury if the malfunction were to recur;                                         |

| ● | corrections                                                                                                                         
 and removal reporting regulations, which require that manufactures report to the FDA field corrections or removals if undertaken to 
 reduce a risk to health posed by a device or to remedy a violation of the FDCA that may present a risk to health;                   |

| ● | complying                                                                                                                                
 with federal laws and regulations requiring Unique Device Identifiers on devices and submission of certain information about each device 
 to the FDA’s Global