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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. The Points is an upgraded version of Practice for Cosmetics Production Licensing , implemented in 2016, with more stringent inspection requirements.

FDA 75
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Unimpressed Learned Intermediaries Defeat Warning Causation

Drug & Device Law

The law presumes that licensed doctors know what they are doing. 1978), where a hypertensive patient was injured after being injected with the defendant’s drug – despite warnings that “expressly directed the doctor administering the drug to refrain from giving it to a patient with hypertension.” 2001), aff’d , 358 F.3d

Doctors 59