Draft Guidance for Industry and Food and Drug Administration Staff – Postmarket Management of Cybersecurity in Medical Devices – This guidance document is being distributed for comment purposes only. Document issued on: January 22, 2016.
“FDA is issuing this guidance to inform industry and FDA staff of the Agency’s recommendations for managing postmarket cybersecurity vulnerabilities for marketed medical devices. In addition to the specific recommendations contained in this guidance, manufacturers are encouraged to address cybersecurity throughout the product lifecycle, including during the design, development, production, distribution, deployment and maintenance of the device. A growing number of medical devices are designed to be networked to facilitate patient care. Networked medical devices, like other networked computer systems, incorporate software that may be vulnerable to cybersecurity threats. The exploitation of vulnerabilities may represent a risk to the safety and effectiveness of medical devices and typically requires continual maintenance throughout the product life cycle to assure an adequate degree of protection against such exploits. Proactively addressing cybersecurity risks in medical devices reduces the patient safety impact and the overall risk to public health…”