Hall Render

NOVEMBER 30, 2023

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”).

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FDA Public Health Compliance Hospitals 40

Hall Render

JUNE 5, 2024

In April 2024, the Food and Drug Administration (“FDA”) issued a Final Rule amending the definition of in vitro diagnostics products (“IVDs”) found in 21 C.F.R. This phaseout is scheduled to occur over four years, starting from the publication date of the Final Rule on May 6, 2024.

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FDA Compliance Regulatory Compliance Licensing 40

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. A concerted and collaborative effort is essential to address this threat to global health, economies, and security effectively.

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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. PCPCs current priority is to work with the FDA to effectively implement the Modernization of Cosmetics Regulation Act of 2022.

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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. PCPC’s current priority is to work with the FDA to effectively implement the Modernization of Cosmetics Regulation Act of 2022.

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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.

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FDA Compliance Public Health World Health 52

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