FDA Issues Draft Guidance on Cybersecurity of Medical Products

(10/18, Arndt, Subscription Publication) reports the FDA issued a draft guidance, called the “cybersecurity bill of materials,” that would require “medical device manufacturers to package their products with a list of their hardware and software components.” The FDA says, “A cybersecurity bill of materials can be a critical element in identifying assets, threats and liabilities.” The article adds that the requirement aims to help risk assessments and ensure “there are proper safeguards in place to keep the devices functioning” as medical “devices with network connections become more common.”

 

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