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Following several cases highlighting medical device cybersecurity vulnerabilities and concerns from experts and lawmakers about the federal government's response, FDA is joining with Homeland Security and the National Science Foundation to hold a two-day workshop to discuss potential gaps and how to fix them.
Latest From United States, Policy &Regulation
When asked about Cures-related hiring, the FDA drug-center director says to her knowledge, no funding has been received yet.
In this hour-long webinar, Medtech Insight's Amanda Maxwell and David Filmore, and In Vivo's Ashley Yeo discuss regulatory reforms in the works for in vitro diagnostics in the EU and US.
Two House Committee leaders are asking HHS Secretary Tom Price about the current status of an overdue pandemic influenza preparedness plan, including diagnostic advancements, that was promised last August. The lawmakers say they are worried about a US return of the H7N9 avian influenza virus, which re-emerged in China earlier this year.
A patient's point of view is paramount as the Center for Devices and Radiological Health embarks on a plan to conduct patient-perspective studies to ascertain what device-users want and value when it comes to health care. But don't call it a "survey" – "this is real research," CDRH compliance chief Robin Newman says.
Two US FDA advisory committee meetings are scheduled for May. One will delve into a new organ-transplant device intended to keep organs viable longer, while the other will present recommendations on how the agency should spend funds from the 21st Century Cures Act.
BIO and AdvaMed offered multiple concerns about a January US FDA draft guidance formalizing the pre-RFD process, including that the timeline is too long and that the recommended information may not land manufacturers a center designation.
Latest From United States &Quality Control
Following a voluntary recall from Medtronic of its StratMR adjustable valves and shunts, US FDA has issued the highest level of recall for the devices, stating they could severely injure patients or cause death.
FDA investigators are concerned Abbott's St. Jude Medical subsidiary failed to adequately address concerns over cybersecurity vulnerabilities and premature battery drain on their cardiac devices manufactured at its Sylmar, Calif., facility.
Members of the House Energy & Commerce Health Subcommittee probed FDA device-center chief Jeff Shuren about the agency's nascent efforts to improve facility inspections during a recent hearing on user-fee reauthorization. Lawmakers say they are hearing complaints from constituents about a lack of consistency and transparency in FDA inspection practices. Bills have now been introduced in both the House and Senate to address the issue, while FDA embarks on its "program alignment" upgrade to its inspections program.
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