International Medical Device Regulatory Monitor
March 2011 | Vol. 19 No. 3 | Full Issue in PDF Format
The UK has delayed for the second time the implementation of the UK Bribery Act, which outlines criminal offenses for bribery in the commercial sector.
H.R. 1, the continuing resolution (CR) that would fund the U.S. Food and Drug Administration (FDA) for fiscal 2011, would allocate $318.8 million to the agency’s device programs, a 13 percent decrease from the $367 million appropriated in fiscal 2010.
With the European Parliament’s consent for enhanced cooperation, a common EU patent system may become a reality.
Eucomed has submitted four proposals on the European Commission’s (EC) Innovation Partnership on Active and Healthy Ageing, pointing out barriers to improved medical technology innovation.
Eucomed is urging tighter notified body control, rather than a shift from the EU’s decentralized regulatory approach, in upcoming revisions to the EU’s Medical Device Directives.
Safety and industry experts are questioning a study that claims the device regulatory system in Europe is as safe as in the U.S., despite the EU’s reputation for putting devices in the market faster.
Quality problems with metal-on-metal (MoM) hip replacement systems, like Johnson & Johnson (J&J)’s ASR devices, may not be as widespread as UK data indicates, the U.S. Food and Drug Administration (FDA) says.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance for manufacturers and regulators of endometrial ablation devices in response to an increasing number of device-related adverse events associated with the treatment.
Colorectal cancer diagnostics makers could see benefits from new European Commission guidelines, which push use of the diagnostics to reduce the disease’s mortality rate by up to 15 percent.
The European Commission’s (EC) formal objection to 11 international medical device standards may not mean the harmonizing guidelines are rife with problems, but instead that the system is evolving to become more international instead of focusing on European requirements.
Australian devicemakers are conflicted over several proposals from the Therapeutic Goods Administration (TGA) but are overwhelmingly arguing against the inclusion of the Australian register of therapeutic goods (ARTG) number on product labeling.
As the Canadian life sciences sector recovers from the global recession, a survey shows the industry wants government to increase its support as funding difficulties continue.
For the second year in a row, Health Canada’s Medical Devices Bureau (MDB) struggled to issue market authorizations in a timely manner in 2010.
Certain in vitro diagnostic (IVD) submissions to Australia’s Therapeutic Goods Administration (TGA) are now subject to mandatory application audits, according to a new guideline. Includes the full text of TGA’s Application Audit for IVD Medical Devices.
As talks to reauthorize the U.S. Medical Device User Fee and Modernization Act (MDUFMA) get underway, the device industry plans to request new metrics to ensure more timely processing of 510(k) and premarket approval (PMA) submissions.
As more smart phone applications capable of performing medical tasks make their way to market, traditional devicemakers should be prepared for an adverse impact on revenues, design strategies and intellectual property (IP) management.
One of the U.S. Food and Drug Administration’s (FDA) departments is creating a new pathway to expedite approval of the most innovative devices — an about-face from its reaction to a similar proposal.
Devicemakers nervous about seeing their executives targeted for criminal prosecution under the U.S. Food and Drug Administration’s (FDA) stepped-up enforcement campaign based on the Park doctrine have received some insight into the factors the agency considers when pursuing such cases.
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