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R&D Engineering, a maker of kidney transport trays, received an FDA warning letter for failing to secure identification labels on devices, among other quality issues. Read More
The FDA roundly rejected a citizen’s petition from the Minnesota Medical Device Alliance that had sought multiple changes to the 510(k) notification process. Read More
Manufacturers of moderate-risk devices with a good record of GMP compliance could see less of government inspectors, under proposed amendments to South Korea’s good manufacturing practice regulations. Read More
Manufacturers of medical devices that contain nanomaterials should use a phased approach to evaluate risk in order to avoid unnecessary testing, an expert committee of the European Commission recommends. Read More
Democratic lawmakers pressed President Barack Obama last week to use his executive authority to bar U.S. corporations from dodging taxes by acquiring a smaller foreign business and moving their headquarters overseas. Read More
With five new medical device regulations set to take effect in China on Oct. 1, industry insiders are worried the short transition period will affect supply of products in the country. Read More
Manufacturers of home-use devices should conduct usability tests early in design development and at later stages as the product evolves to ensure that user interaction problems caused by human factors have been addressed, the FDA says in final guidance released Tuesday. Read More
Sites should state clearly what patients can expect regarding access to personal results from clinical trials in their informed consent documents, an expert witness told the Secretary’s Advisory Committee on Human Research Protections in Rockville, Md., on July 22. Read More
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