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Set Alert for Policy and Regulation United States

Feds Holding Workshop on Medical Device Cybersecurity Gaps

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.

Regulation Safety Medical Device
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Latest From United States, Policy &Regulation

US FDA Still Waiting For Cures Money, Woodcock Says

When asked about Cures-related hiring, the FDA drug-center director says to her knowledge, no funding has been received yet.

FDA Policy

Webinar: What's Ahead For IVD Regulations In The EU And US

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.

In Vitro Diagnostics Regulation

HHS Pressured By Lawmakers To Release Pandemic-Flu Plan

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.

In Vitro Diagnostics Infectious Diseases

The Patient Perspective: Upcoming US FDA Device Center Studies Put Device-Users In Front Seat

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.

FDA Medical Device

AdComms To Meet On TransMedics Organ Transplant Device, Discuss '21st Century' Funds

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.

FDA Advisory Committees

Device Trade Groups Offer Lukewarm Comments On Pre-RFD Draft

BIO and AdvaMed offered multiple concerns about a January US FDA draft guidance formalizing the pre-RFD process, including that the timeline is too long and that the recommended information may not land manufacturers a center designation.

Combination Products Review Pathway
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Latest From United States &Quality Control

Medtronic StratMR Device Gets Class I Recall

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.

Recalls Safety

US FDA Warning Letter Scrutinizes Abbott Over Cybersecurity, Battery Lapses

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.

Regulation Compliance

House Subcommittee Grills Shuren On Facility Inspection Shortfalls

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.

Legislation Quality Control
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