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FDA’s 2018 Cybersecurity Guidance Overview
Previously in 2014, the FDA has published a final guidance discussing premarket expectations but the constant technology advancements and changes requires a new guidance. As a result, on October 18, 2018, the FDA...
FDA Announces Medical Device Reporting Changes
The US medical device regulating authority, the FDA, terminated the Alternative Summary Reporting Program, used for reporting for over 10 years. Medical device manufacturers exempted from reporting were informed that...