On October 2, 2014 the FDA issued a guidance that reflects current thinking on management of
cybersecurity in medical devices. Device manufacturers are encouraged to consider potential threats of hackers and security breaches in the research, design, and development of medical devices. The FDA further recommends incorporating device protection plans into premarket submissions. This has the potential to increase costs in all phases of production.
Topics: Medical Devices, FDA Guidance, Cybersecurity

