FDA Outlines Next Steps For Online Repository And Standard Elements For Device Labeling
This article was originally published in The Gray Sheet
Industry representatives, health care providers, patients and caregivers gathered April 29-30 to discuss CDRH labeling activities and the agency’s ideas for the future.
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Daniel Troy suggests FDA increase its investment in science of consumer understanding, while Richard Cooper recommends the "bully pulpit" approach to get industry's attention. A panel of former chief counsels stressed that the agency cannot continue to ignore First Amendment free speech issues.
FDA plans cognitive study of health care practitioners this summer to advance efforts to standardize the structure and content of medical device labeling
FDA’s device center issued a request to participate for a pilot asking companies to electronically submit labeling for home-use devices to help develop a label database. This is the agency’s second go at such a pilot but the submissions process appears to be simplified this time around.