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.

FDA 40

FDA Compliance Regulatory Compliance Licensing 40

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.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 40

SQA

MAY 24, 2023

The deadline for reporting serious incidents not constituting serious public health threats, deaths, or unanticipated serious deteriorations in state of health was reduced to 15 calendar days. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

FDA 40

FDA Licensing Governance Compliance 40

SQA

OCTOBER 18, 2024

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

FDA 52

FDA Compliance Public Health World Health 52

New Jersey Healthcare Blog

JANUARY 12, 2022

Below are the most recent health care related regulatory developments as published in the New Jersey Register from October-December 2021: On October 4, 2021, at 53 N.J.R. 103, which declared a Public Health Emergency for the state in response to COVID-19. Effective September 28, 2028. See N.J.A.C. 10:101 as N.J.A.C.

Licensing 40

Licensing Medicaid Medicaid Nurses 40

SQA

OCTOBER 18, 2024

NPMA Issues Draft Guidelines for Inspection of Medical Device Clinical Trial Sites, 14 June 2024 China NMPA has released a new guideline that aims to enhance the management of clinical trial institutions for medical devices, ensuring compliance with regulatory standards and safeguarding public health.

FDA 40

FDA Compliance Public Health Governance 40