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MarCor Purification, a maker of water purification systems for the life sciences, has been warned by the FDA over CAPAs, investigations and complaint handling. Read More
Manufacturers can expect more guidance on how to conduct patient preference research during device development, thanks to a $500,000 FDA grant to the Medical Device Innovation Consortium. Read More
Devicemakers will be able to submit traditional 510(k)s electronically to two CDRH device branches, under an experimental program announced Thursday. Read More
The FDA’s Denver office will host a two-day public workshop on global drug and device safety during an educational conference sponsored by the Association of Food and Drug Officials. Read More
LumiQuick Diagnostics received an FDA warning letter after an investigator saw employees assembling a drugs of abuse test panel and an amphetamine test strip on the same table. Read More
A group of FDA task forces has recommended that the agency expand the amount of information it releases on inspections and enforcement, allowing the public to view a more detailed record of a company’s compliance history. Read More