Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 388

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 388
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 Unique Device Identification Database;                                                                               |

| ● | the                                                                                                                          
 FDA’s recall authority, whereby the FDA can order device manufacturers to recall a medical device from the market if the FDA 
 finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death; and  |

| ● | post-market                                                                                                                          
 surveillance regulations, which apply when deemed by the FDA to be necessary to protect the public’s health or to provide additional 
 safety and effectiveness data for the device.                                                                                        |

| 209 |

Quality Systems Regulation Requirements

Manufacturing of medical devices must comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation, and servicing of finished devices intended for human use. The QSR requires that each manufacturer establish a quality systems program by which the manufacturer monitors the manufacturing process and maintains records that show compliance with FDA regulations and the manufacturer’s written specifications and procedures relating to the devices. The QSR also requires, among other things, maintenance of records and certain documentation, a device master file, device history file, and complaint files. QSR compliance is necessary to receive and maintain FDA clearance or approval to market new and existing products. Our or our manufacturer’s failure to maintain compliance with the QSR or other applicable regulatory requirements could result in the shut- down of, or restrictions on, manufacturing operations and the recall or seizure of our products. The discovery of previously unknown problems with any of our products, including unanticipated adverse events or adverse events of increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label by a physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market or voluntary or mandatory device recalls.

The FDA has broad regulatory compliance and enforcement powers. If the FDA determines that a manufacturer has failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in any of the following sanctions:

| ● | warning                                                                                                                            
 or untitled letters, FDA Form 483s, It Has Come To Our Attention letters, fines, injunctions, consent decrees and civil penalties; |

| ● | customer                                                                                     
 notifications or repair, replacement, refunds, recall, detention or seizure of our products; |

| ● | operating                                                         
 restrictions, partial suspension or total shutdown of production; |

| ● |