FDA Provides More Guidance to Shield Medical Devices from Cyber Attacks
The Food and Drug Administration has issued preliminary guidance pinpointing cybersecurity concerns that manufacturers should consider when developing medical devices.
The Food and Drug Administration has issued preliminary guidance pinpointing cybersecurity concerns that manufacturers should consider when developing medical devices.
The Food and Drug Administration has recently announced a program that actively encourages the development of medical digital technology, including wireless wearables and applications that can monitor blood pressure and heart rate, track intake of calories, and measure physical activity.
The program is designed to give pre-clearance to developers working on digital health products, as the approval process for apps sometimes includes burdensome regulations, which can increase costs and limit innovation: the FDA hopes to reduce development costs and give entrepreneurs increased opportunities to develop products.