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The FDA has warned Vention Medical’s Barreal de Heredia, Costa Rica, facility over environmental controls, equipment upkeep and other quality issues. Read More
The FDA has warned Masimo’s Irvine, Calif., facility over complaint issues, failure to establish and maintain procedures for implementing corrective and preventive action, and failure to investigate the causes of nonconformities. Read More
Devicemakers are asking the FDA to retain the current classification scheme for Class III devices, saying a proposal to establish risk-based categories would require PMAs for many more devices than currently undergo full premarket approval. 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
The FDA has asked Spacelabs Healthcare, a maker of patient monitoring devices, to get an audit from an outside consultant to address problems with corrective and preventive actions and MDRs. Read More
ProTech Professional Products received an FDA warning letter for problems with its corrective and preventive action and complaint procedures and for failing to notify the FDA of significant device modifications. 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 regulation. Read More
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
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
Traditional methods for training new employees may be failing devicemakers, as most Form 483 observations can be traced back to training deficiencies, several experts say. Read More