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Two years after the FDA proposed using device registries as tool to strengthen postmarket surveillance, some healthcare groups are saying the agency has not done enough to make that happen. Read More
The FDA has warned Winter Park, Fla., devicemaker Iradimed for failing to initiate and validate corrective actions related to its infusion pumps and sets. Read More
Devicemakers are urging the Centers for Medicare & Medicaid Services to maintain the current exemption on reporting financial support for continuing medical education programs under the Physician Payment Sunshine Act, a policy threatened by a proposed rule. Read More
With FDA investigators soon to begin scrutinizing UDI compliance, Class III devicemakers should prepare by ensuring that UDI changes in design history files are adequately documented and that the company has a verification process for barcodes in place. Read More
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