The US Food and Drug Administration released on Monday its final rule to regulate laboratory-developed tests (LDTs).
DiaCarta said Monday that it has formed a strategic partnership with New Jersey-based contract research organization Hopkins MedTech Compliance/Hopkins MedTech Lab Services to provide validation and regulatory compliance services for laboratory test and in vitro diagnostic developers in the US.
In October 2022, the Office of the Leading Group for Deepening Medical and Health System Reform in Shanghai issued the Notice on Piloting the High-Quality Development of Public Hospitals in Shanghai.
On October 15, the General Office of Hangzhou Municipal People's Government issued the "Notice on Several Measures to Accelerate the High-Quality Development of Biomedical Industry"
Those working in the industry will be aware that the implementation of the IVDR has been far from straightforward, and that there is still a lot of work to be done.
Consumer advocates say the proposed legislation has too many exemptions, while industry groups seek to limit premarket review requirements for legacy tests.
Genetron Health on Tuesday reported a 38 percent year-over-year increase in its second quarter revenues amid strong growth in sales from its LDT and IVD segments.
FDA will not require developers to submit a premarket approval application, premarket notification or emergency use authorization for laboratory developed tests, the Department of Health and Human Services announced on August 19th.
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