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Must investigators obtain informed consent anew in order to use aggregated clinical trial data for secondary purposes? What purpose does this data serve to improve standards of care? And are there risks inherent in using such data? Read More
Evaluations of diagnostic test accuracy studies should include separate meta-analysis of positive and negative likelihood ratios, according to a draft guideline by the EU Network for Health Technology Assessment. Read More
Sponsors designing clinical trials that involve certain vulnerable patient populations will soon face greater scrutiny from institutional review boards, under newly issued FDA guidance. Read More
CareFusion received an FDA warning letter for failing to analyze debris and particulate matter on its shunts and inside peritoneal catheters and tubing. Read More
Before manufacturers complete their risk-management processes, they should perform a risk-benefit analysis for any risks that are unacceptable under Annexes Z in EN ISO 14971: 2012, and for which further risk reduction is possible, according to a draft consensus paper from the EU-based Notified Body Recommendation Group.
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The device industry is asking the FDA not to impose controls, including quality system regulations, on manufacturers of low-risk health information management software that doesn’t serve a clinical function. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is strengthening its ability to respond to postmarket medical device safety issues by creating a fast-acting committee of expert advisors that can rapidly review safety problems. Read More
Ventlab received an FDA warning letter for its handling of complaints and a corrective and preventive action related to nonconforming manual resuscitation bag components. Read More
Med-Mizer, a maker of electric, adjustable and bariatric hospital beds, received an FDA warning letter for failing to submit a timely MDR following a patient death. Read More