FDA Outlines Cybersecurity Recommendations for Medical Device Manufacturers

By Eric Noonan • January 21, 2016

The FDA recently issued draft guidance entitled “Postmarket Management of Cybersecurity in Medical Devices” and once again NIST is setting the standard as a recommended framework, specifically the NIST “Framework for Improving Critical Infrastructure Cybersecurity.” The draft guidance issuance date is January 22, 2016, CyberSheath has expanded on what this guidance means for medical device manufacturers in a recent blog post, below you can review the FDA press release and draft guidance.

Cybersecurity Recommendations for Medical Device Manufacturers:

Official FDA Press Release

Official Draft Guidance Entitled “Postmarket Management of Cybersecurity in Medical Devices”

Submit Comments and Suggestions on Draft Guidance

Interested parties should “submit comments and suggestions regarding the draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 or submit electronic comments. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.”

How Can CyberSheath Help Your Organization?

The FDA guidance continues a trend where the government is using its ability to influence industry and improve cybersecurity across every critical infrastructure sector. CyberSheath will work with your organization, large or small, to understand the NIST framework recommended within the FDA draft guidance. CyberSheath offers security assessments to help your organization begin with a clear understanding of where you stand in regards to industry standards and regulations.

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