Hall Render

JUNE 5, 2024

Stage 4: Effective November 6, 2027 Approximately three and a half years after the publication of the Final Rule, high-risk (Class III) IVDs offered as LDTs must comply with premarket review requirements. The FDA notes that it will continue to exercise enforcement discretion during the review of premarket submissions received by this stage.

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Hall Render

NOVEMBER 30, 2023

This modification means that all IVDs, including LDTs, will be required to comply fully with FDA’s medical device regulatory requirements, including registration and listing, premarket review, post-market reporting requirements and compliance with the FDA’s Quality System Regulation ( 21 C.F.R. Part 820 ), unless they fall under an exemption.

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Verisys

JANUARY 13, 2022

The State of Alabama state of emergency Proclamation by the Governor which extended the public health emergency until Oct. This public health order included: Emergency care in hospitals. The Indiana Executive Order 21-28 was passed to extend the public health disaster emergency only until Dec. California.

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Healthcare Law Blog

AUGUST 25, 2022

After 2026, the timing for publication is standardized – the February 1 st two years prior to the price applicability date will be the drug publication date. Fifteen more Part D drugs are set to be published in 2027, followed by 15 Part D and Part B drugs, collectively, in 2028. Program Compliance.

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SQA

MAY 24, 2023

ANVISA Resumes Inspections in the Area of Technovigilance, 29 March 2023 In partnership with local Health Surveillance, ANVISA technical teams carried out in March 2023 two (2) medical device manufacturer inspections with an aim to strengthen the monitoring of these products in Brazil, ensuring their safety, performance, and quality.

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SQA

FEBRUARY 15, 2023

ICMRA recognizes that AMR is a complex, multifaceted problem and calls for better coordination across all sectors, including public health, animal health, and the environment, through a ‘One Health’ approach. Tackling AMR is one of ICMRA’s strategic priorities.

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