Company: FTII
Filing Date: 2025-02-14
Form Type: S-4
Source: 0001493152-25-006997
Chunk: 156

Company: FutureTech II Acquisition Corp.
Filing Date: 2025-02-14
Form: S-4
Chunk 156
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 and approvals or certifications can often be denied or significantly delayed. We may not obtain the
necessary approvals or certifications and failure to obtain timely regulatory approval or certification, if at all, would adversely affect
our business.

We are not permitted
to commercialize, market, promote or sell any of our product candidates in the United States without obtaining approval from the FDA.
The time required to obtain approval or certification by the FDA and comparable foreign regulatory authorities is unpredictable, typically
takes many years following the commencement of clinical studies and depends upon numerous factors, including the type, complexity and
novelty of the product candidates involved. In addition, requirements for approval, including the type and amount of clinical data necessary
to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions, which
may cause delays in the approval, certification or the decision not to approve an application. Regulatory authorities have substantial
discretion in the approval or certification process and may refuse to accept any application or may decide that our data are insufficient
for approval or certification and require additional preclinical, clinical or other studies.

In the United
States, before we can market a new medical device, or a new use of, or significant modification to an existing device, we must first receive
either clearance under Section 510(k) of the FDCA, or approval of a PMA application from the FDA, unless an exemption applies. 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 manufacturer and regulatory control needed to ensure its safety and effectiveness. Certain
Class I and Class II devices are exempt from premarket notification (510(k)) requirements as well as the Medical Device cGMPs, also referred
to as the QSR. A Class I or Class II device that is exempt from 510(k) requirements must still comply with other requirements unless the
device is explicitly exempt from those requirements as indicated in the regulation for that device type. In the process of obtaining PMA
approval, the FDA must determine that a proposed device is safe and effective for its intended use(s) based, in part, on extensive data,
including, but not limited to, technical, preclinical, clinical, manufacturing and labeling information. The PMA process is typically
required for devices that are deemed to pose the greatest risk, such as life-sustaining, life-supporting or implantable devices