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The FDA is taking steps to address cybersecurity vulnerabilities in medical devices but needs to foster more cooperation between stakeholders to encourage timely reporting of cybersecurity incidents, Rep. Diana DeGette (D-Colo.) said in an interview. Read More
The FDA has announced that it will not release final guidance on laboratory developed tests (LDTs), and instead will work with Congress and other stakeholders to determine how LDTs… Read More
The International Medical Device Regulators Forum has developed guidance outlining the steps required to generate clinical evidence of effectiveness and safety of software as a medical device (SaMD). Read More
Medicare spent $1.5 billion and patients spent $140 million as a result of just seven recalled or failed cardiac devices, spending that could be better controlled if unique device identifiers (UDIs) were required on CMS claim forms, according to a report by the HHS Office of Inspector General (OIG). Read More