Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Minnesota device makers petition FDA. Invacare lays off workers following FDA consent decree. More regulatory news.
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Regulatory News In Brief
Johnson & Johnson/LifeScan is recalling nearly 2 million blood glucose meters in the U.S. and overseas. Court rules in favor of FDA in Cytori 510(k) substantial equivalence case. More regulatory news.
FDA Says Pilot On Standard Electronic Labeling For Devices “Didn’t Work”
CDRH’s five-company pilot study on electronic transmission of standard device labeling information spotlighted some serious challenges with the practice, according to a policy advisor at the center.
FDA’s Revised Electronic Source Data Guidance Less Specific On How Data Should Flow
FDA issues its second draft on the topic in two years, going back to the drawing board after comments from industry, but BIO still hasn’t persuaded the agency to explicitly exempt electronic diaries.