Tag Archives: Medical Devices

FCC Seeks Comment on Proposal to Change Device Marketing Rules

The Federal Communications Commission (“FCC”) is seeking comment on a Notice of Proposed Rulemaking (“NPRM”) that would modify certain aspects of the FCC’s device authorization rules.  Specifically, the FCC is seeking comment on a proposed revision to its device authorization rules to allow the importation of limited quantities of radiofrequency (“RF”) devices prior to authorization … Continue Reading

FCC Plans to Advance Proposal to Change Device Marketing Rules

In what is expected to be one of the last meetings under the leadership of current Federal Communications Commission (“FCC”) Chairman Ajit Pai, the agency will consider adopting a Notice of Proposed Rulemaking (“NPRM”) that proposes to modify certain aspects of the FCC’s device authorization rules.  Specifically, the NPRM will propose to allow the importation … Continue Reading

US Information Security and Privacy Board Expresses Concerns about Management of Cybersecurity in Wireless Medical Devices

The US Information Security and Privacy Board (ISPAB) voiced concerns over potential harms resulting from a lack of controlled management of cybersecurity in wireless medical devices in response to the FDA’s  draft guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.”  ISPAB operates under the National Institute of Standards and Technology (NIST) in … Continue Reading
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