Company: SXTPW
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003343
Chunk: 59

Company: 60 DEGREES PHARMACEUTICALS, INC.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 59
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 including appropriate clinical or scientific data, if deemed necessary by the FDA, that demonstrates
that the device is as safe and as effective as a legally marketed device, and (ii) does not raise different questions of safety and effectiveness
than the predicate device. Most 510(k)s do not require clinical data for clearance, but the FDA may request such data. The FDA seeks
to review and act on a 510(k) within 90 days of submission, but it may take longer if the agency finds that it requires more information
to review the 510(k). If the FDA concludes that a new device is not substantially equivalent to a predicate device, the new device will
be classified in Class III and the manufacturer will be most likely required to submit a PMA to market the product.

Under the PMA application process, the applicant
must demonstrate that the device is safe and effective for its intended use. This PMA approval process applies to most Class III devices,
and generally requires clinical data to support the safety and effectiveness of the device, obtained in conformance with Investigational
Device Exemption regulations. The FDA will approve a PMA application if it finds that there is a reasonable assurance that the device
is safe and effective for its intended purpose, and that the proposed manufacturing is in compliance with the QSRs. For novel technologies,
the FDA will seek input from an advisory panel of medical experts regarding the safety and effectiveness of, and their benefit-risk analysis
for the device. The PMA process is generally more detailed, lengthier and more expensive than the 510(k) process, though both processes
can be expensive and lengthy, and require payment of significant user fees, unless an exemption is available.

Modifications to a 510(k)-cleared medical device
may require the submission of another 510(k) or a PMA if the changes could significantly affect safety or effectiveness or constitute
a major change in the intended use of the device. Modifications to a 510(k)-cleared device frequently require the submission of a traditional
510(k), but modifications meeting certain conditions may be candidates for FDA review under a Special 510(k). If a device modification
requires the submission of a 510(k), but the modification does not affect the intended use of the device or alter the fundamental technology
of the device, then summary information that results from the design control process associated with the cleared device can serve as
the basis for clearing the application. A Special 510(k) allows a manufacturer to declare conformance to