FDA to Update Premarket Guidance for Medical Device Security

FDA Commissioner Scott Gottlieb, on 5th September said, “FDA is planning to update its premarket guidance for medical device security.” He further added, “We have made significant progress to improve the cybersecurity of medical devices. But the industry is rapidly evolving with respect to data security and we need to keep up the pace.”

This guidance will have recommendations for manufacturers for the protection against moderate and major ricks which are capable of disrupting & exploiting clinical operations through remote attack.

He further added that the FDA will share number of actions that can help strengthen device cybersecurity. These efforts aim to protect against attacks and enhance respective response to various cyber vulnerabilities.

In April 2018, the FDA first release this medical device safety action plan targeting better security against attacks such as ransomware which result into catastrophic consequences. Earlier to this, in 2016, the FDA has also completer its post markets guidance for cybersecurity. The FDA is also planning to have new postmarket authority to help manufacturers adopt policies and procedures. The FDA had earlier announced its National Evaluation System for health Technology (NEST) for more efficient generation of better evidence for medical device evaluation and regulatory decision-making. The FDA will further seek additional funding in 2019 to help NEST turn into a more active surveillance tool.