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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 – Spring

SQA

Requirements for classification and related issues established under RDC 185/2001, as well as other relevant medical device regulations, will apply for SaMD, as well. United States Food and Drug Administration (FDA) – Regulations and Guidances. United States Food and Drug Administration (FDA) – Recalls.

FDA 75
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Health Provider News

Hall Render

nursing homes to pay $4M over claims of substandard care Mass. officials take aim at anti-abortion centers with new public awareness campaign Massachusetts, DC loosen CRNA supervision requirements Nursing home chain with 3 Central Mass. One is still waiting for a contract.

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Health Provider News

Hall Render

How did we get here? Nonprofit hospitals under growing scrutiny over how they justify billions in tax breaks States increase pressure on nonprofit hospitals as charity care scrutinized Senate proposal would give hospitals $385M for emergency preparedness.