Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 58

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 58
---
 reviews and approves the application
for any patent term extension or restoration in consultation with the FDA.

29

Review and Approval of Medical Devices
in the United States 

Medical devices in the United States are strictly
regulated by the FDA. Under the FDCA, a medical device is defined as an instrument, apparatus, implement, machine, contrivance, implant,
in vitro reagent, or other similar or related article, including a component part, or accessory which is, among other things:
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in
man or other animals; or intended to affect the structure or any function of the body of man or other animals, and which does not achieve
its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being
metabolized for the achievement of any of its primary intended purposes. This definition provides a clear distinction between a medical
device and other FDA regulated products such as drugs. If the primary intended use of the product is achieved through chemical action
or by being metabolized by the body, the product is usually a drug. If not, it is generally a medical device.

Medical devices are classified into one of three
classes on the basis of the controls deemed by the FDA to be necessary to reasonably ensure their safety and effectiveness. Class I devices
have the lowest level or risk associated with them, and are subject to general controls, including labeling, premarket notification and
adherence to the Quality System Regulation (“QSR”). Class II devices are subject to general controls and special controls,
including performance standards. Class III devices, which have the highest level of risk associated with them, such as life sustaining,
life supporting or some implantable devices, or devices that have a new intended use, or use advanced technology that is not substantially
equivalent to that of a legally marketed device, are subject to most of the aforementioned requirements as well as to premarket approval.

A 510(k) must demonstrate that the proposed device
is substantially equivalent to another legally marketed device, or predicate device, which did not require premarket approval. In evaluating
a 510(k), the FDA will determine whether the device has the same intended use as the predicate device, and (a) has the same technological
characteristics as the predicate device, or (b) has different technological characteristics, and (i) the data supporting substantial
equivalence contains information,