Pathways Picks April 6: Cyber, CMS Docs Upcoming, Senate Hearing, Global Picks

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In this week’s roundup: We are looking for an imminent release of FDA’s revised premarket cybersecurity draft guidance and CMS proposed hospital inpatient rule; MCIT conversation continues; free OTC COVID tests; Senate holds user fee hearing; Rep. Upton retiring; Brazil takes next step on pricing database; and news from China, the UK, and EU.

Next Picks: Cybersecurity Guidance, Inpatient Rule

What we’re watching for:

FDA’s cyber guidance. The agency has been working on a revision to its guidance on premarket cybersecurity requirements for devices over the past several years, and we expect the new draft out very soon. The White House Office of Management and Budget completed its review of the draft this week. Typically that means release of the document could be imminent unless OMB requested substantive changes. FDA first finalized guidance on premarket cybersecurity considerations in 2014. It attempted a revised draft in 2018 but subsequently decided to rework that document, in particular to put more emphasis on standards for “transparency, resiliency, and trustworthiness.” (See, “FDA Targets Medtech Cybersecurity: An Interview with Kevin Fu, the First Device Cyber Czar,” Market Pathways, March 4, 2021.) The pending revised draft also will address “quality system considerations.” The new draft guidance will come out just as Congress is considering attaching legislation to user fee reauthorization that would codify minimum premarket cybersecurity requirements in federal law.


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