US FDA has developed a two-tiered system for assessing the cybersecurity risk level of a medical device in a new draft guidance intended to update a 2014 document. The new draft, addressing pre-market cybersecurity recommendations for device companies, also directs device-makers include a cybersecurity "bill of materials" and makes other labeling recommendations.
The agency released the draft guidance this week after officials have been signaling plans for the updates for the past several months. At 24 pages, it is significantly more...