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Legal, Clinical & Regulatory

FDA Priorities: People, Simplicity and a Risk-Based Approach to Speed Time to Market

By utilizing a more straightforward methodology, FDA can free up and better use resources to focus on high-risk areas that have the biggest impact. "Simplicity requires that FDA remain limber," writes John Gagliardi. "For industry to be innovative, the federal government must be innovative as well."

Can You Trust E-Signatures From Your Software Package Vendor?

Martin Browning from EduQuest provides insight into the validity of e-signatures from vendors: "Validation must include documentation, or it is not validation. At a minimum, you must establish (note the regulatory meaning of that word) the validity of the e-signatures you want to accept based on your intended use."

FDA Takes Several Steps to Strengthen Medical Device Cybersecurity Program

In order to stay current with the evolving technological landscape and increased insight into cyber threats, FDA recently addressed cybersecurity, including updating previous guidance, a new cybersecurity playbook and a program with the Department of Homeland Security.