Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software Guidance for Industry January 2005
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Devices and Radiological Health
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2020-D-0957.