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SQA Regulatory Surveillance Summary 4 | Monthly Update 2021

SQA

The new regulation, RDC 478/2021 , repeals economic monitoring and reporting processes previously established under RDC 185/2006, and initially reduces the number of medical device types for which economic monitoring will be required. Due to the COVID-19 pandemic, there was an increase of 39.2%

FDA 52
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SQA Regulatory Surveillance Summary 5 | Monthly Update 2021

SQA

COVID-19 Response: Freely Available ISO Standards, 18 June 2021. A number of ISO standards have been made available to support global efforts to address the COVID-19 crisis. Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. b) and 320.31(d)(3)).

FDA 83
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Supreme Court Halts OSHA Mandatory Large Employer Vaccination Mandate

Drug & Device Law

Using its increasingly notorious “ shadow docket ,” the United States Supreme Court recently stayed operation of the COVID-19 vaccine mandate that the Occupational Safety and Health Administration (“OSHA”) had imposed on large (more than 100 employees) employers nationwide. See National Federation of Independent Businesses v.

COVID-19 105