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Citing industry concerns, the FDA has reversed plans for a proposed voluntary presubmission process that would have allowed sponsors to get reviewer feedback before submitting an investigational device exemption application. Read More
Sponsors are being encouraged to participate in an FDA pilot program aimed at designing and validating regulatory tools for use in developing new technologies. Read More
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
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 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
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 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