article thumbnail

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. FDA plant inspection and pay $50 million in fines and forfeiture. National Research Council.

FDA 52
article thumbnail

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