Medical Devices

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 for pre-sale activities, including imaging, packaging, and delivery to retail locations.  The FCC also is proposing rule revisions that would allow conditional sales, but not delivery, of RF devices to consumers prior to authorization.
Continue Reading FCC Seeks Comment on 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 and conditional marketing and sales of radiofrequency (“RF”) devices that have not yet been approved under the FCC’s rules.  If the rule is ultimately changed, that means companies marketing RF devices for the first time will have the same flexibility enjoyed by some car companies and many other manufacturers to offer a product to the public before it actually can be shipped for use.
Continue Reading FCC Plans to Advance Proposal to Change Device Marketing Rules

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resulting from a lack of controlled management of cybersecurity in wireless medical devices in response to the FDA’s  draft guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.”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 its Computer Security Division, and its goals include identifying emerging managerial, technical, administrative, and physical safeguard issues relative to information security and privacy.
Continue Reading US Information Security and Privacy Board Expresses Concerns about Management of Cybersecurity in Wireless Medical Devices