International Medical Device Regulatory Monitor

Eucomed is calling on the European Commission (EC) to centralize medtech reporting and surveillance, saying the existing vigilance system leads to duplication and uneven health protection across Europe.

Devicemakers in Austria and France are facing new levies as governments look for novel ways to fund their regulatory functions in an austere economy.

By decade’s end, regulatory review of medicines and medical devices will be aligned under a new strategic plan embraced by the Asia-Pacific Economic Cooperation (APEC).

Citing global medtech market shifts, regulators from the U.S., EU, Canada, Australia, Brazil and China, as well as the World Health Organization, started a new group to speed international regulatory harmonization and convergence.

Australia’s Therapeutic Goods Administration (TGA) should step up assessments of Class III medical devices and strengthen postmarket surveillance, the Australian Senate says.

The Australian government is canvassing devicemakers and contract research organizations to gauge the level of privately funded clinical research activity in the country.

EU devicemakers can now display a logo to demonstrate adherence with Eucomed’s ethical business practice code.

Devicemakers may be able to shrink product application fees as much as 70 percent if they can show that a product benefits the public health and its availability can’t be assured if the sponsor must pay in full, Australia’s Therapeutic Goods Administration (TGA) says. Includes the full text of Reduction of Assessment Fees for Medical Devices.

Health Canada’s updated draft list of recognized standards for medical devices includes 10 standards for in vitro diagnostic (IVD) testing.

Companies developing diagnostics for human papillomavirus (HPV) should be alert for the impact of HPV vaccines on the potential test subject population, the U.S. Food and Drug Administration (FDA) says.

Weeks after missing a self-imposed deadline to respond to Institute of Medicine (IOM) recommendations on the 510(k) process, U.S. Food and Drug Administration (FDA) official Jeffrey Shuren told senators at a Nov. 15 hearing he’s unsure when the agency’s response will see daylight.

The U.S. Food and Drug Administration (FDA) proposes to streamline device clinical trials in a pair of draft guidances outlining requirements for early feasibility studies and explaining when a trial can begin even when there are outstanding issues with an Investigational Device Exemption (IDE) submission.

The U.S. device industry and the U.S. Food and Drug Administration (FDA) are closer to an agreement on reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA), but chances are slim that the agency will meet a Jan. 15 goal to deliver that agreement to Congress.

The U.S. Food and Drug Administration (FDA) intends a new draft guidance on development of artificial pancreas device systems to be a map rather than a roadblock, an FDA official said in a Dec. 1 briefing.