A growing number of medical devices are designed to be connected to computer networks. Many of these networked medical devices incorporate off-the-shelf software that is vulnerable to cybersecurity threats such as viruses and worms. These vulnerabilities may represent a risk to the safe and effective operation of networked medical devices and typically require an ongoing maintenance effort throughout the product life cycle to assure an adequate degree of protection. FDA is issuing this guidance to clarify how existing regulations, including the Quality System (QS) Regulation, apply to such cybersecurity maintenance activities.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.