FDA Cybersecurity Guidance For Medical Devices
Friday July 29, 2016
Cybersecurity in the Medical Device Industry
Cybersecurity threats to medical devices are a developing concern in the industry. The manipulation of cybersecurity susceptibilities pose a risk to the safety and efficiency of medical devices. Manufacturers can integrate parts in the product designs for risks prevention, however, it is important that manufacturers consider maintenance improvements of the devices as well. These improvements are vital due to the progressing nature of cyber threats which means that risks may increase all throughout a device’s lifecycle.
The FDA Guidance
In January 2016, the U.S. Food and Drug Administration (FDA) published a guidance draft that includes important steps that should be taken by medical device manufacturers in order to frequently address cybersecurity risks. These steps are crucial so that patients are kept safe and that public health is maintained. According to the FDA, “The draft guidance, Postmarket Management of Cybersecurity in Medical Devices, details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market.” The guidance draft is part of the FDA’s ongoing efforts to guarantee the safety and success of medical devices, at all of their lifecycle stages, in the midst of probable cyber threats.
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