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SQA Regulatory Surveillance Summary | Monthly Update 2022 – June

SQA

The new guidance from the European Medical Device Coordination Group (MDCG) covers “borderline products” not easily categorized either as medical devices falling under MDR requirements or medical products for human use falling under Directive 2001/83/EC (MPD) requirements for CE Marking.

FDA 91
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SQA Regulatory Surveillance Summary | Monthly Update 2022 – September/October

SQA

ANVISA announced major updates to its Resolution of the Collegiate Board of Directors (RDC) 185/2001. It will also facilitate cross-border circulation of these critical health therapies as well as cross-border cooperation between public health authorities.

FDA 40
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A Texas Mess

Drug & Device Law

That Complaint alleges various antivax conspiracy theories concerning COVID-19 vaccines, the FDA, emergency use authorizations, and the media that have circulated since these vaccines first became available. The FDA, however, did not and does not share that belief. FDA (8/23/21) press release (emphasis original).