Company: APM
Filing Date: 2025-07-15
Form Type: DRS
Source: 0001213900-25-063899
Chunk: 303

Company: Aptorum Group Ltd
Filing Date: 2025-07-15
Form: DRS
Chunk 303
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 the FDA believes it can impose
regulatory requirements on LDTs, such as requirements for premarket review, de novo classification, or clearance of LDTs, it has
generally chosen not to enforce those requirements. The FDA has, on occasion, sent warning letters to laboratories offering LDTs that
the agency believed were not eligible for enforcement discretion because of how they were developed, validated, performed, or marketed
and consequent risks to the public.

On May 6, 2024, the FDA published the final rule
on the regulation of LDTs (the “”). The New Rule followed more than a decade of efforts both by the FDA to
clarify the regulatory status of LDTs and Congress to reform the regulatory framework of in vitro diagnostics (IVDs), including LDTs.
The New Rule explicitly stated that IVDs offered as LDTs fall under the FDCA and the FDA would phase out its general enforcement discretion
approach for most LDTs. The New Rule would phase-out enforcement discretion over a period of four years and require compliance with device
registration and listing requirements, medical device reporting requirements, 510(k) clearance, denovo authorization or Premarket Approval
and the requirements of the FDA’s Quality System Regulation.

However, on March 31,
2025, the U.S. District Court for the Eastern District of Texas vacated the FDA’s final rule that aimed to regulate laboratory-developed
tests as medical devices under the Federal Food, Drug, and Cosmetic Act. The court ruled that the FDA lacked the statutory authority
to classify LDTs—diagnostic tests developed and used within a single laboratory—as medical devices, emphasizing that LDTs
are professional medical services, not tangible products subject to FDA regulation.

This
decision halts the FDA’s plan to phase out its general enforcement discretion over LDTs, which would have introduced new compliance
obligations over a four-year period. The court’s ruling underscores that oversight of LDTs falls under the CLIA, administered
by the Centers for Medicare & Medicaid Services (CMS), not the FDA. The FDA had until May 30, 2025, to appeal the decision, but
decided against filing an appeal in May 2025.

HIPAA and HITECH

Under the provisions of the Health Insurance Portability
and Accountability Act, or HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, the
United States