International Medical Device Regulatory Monitor
November 2011 | Vol. 19 No. 11 | Full Issue in PDF Format
Equipment intended specifically for sterilizing or disinfecting medical devices would be designated Class B (low-moderate hazard), under proposed guidance issued by the Global Harmonization Task Force’s (GHTF) Study Group 1.
Medical devicemakers would have to show, through risk analysis and risk management, that animal tissues or derivatives used to produce devices are safe and clinically beneficial and lack suitable alternatives, according to a draft regulation issued Oct. 4 by the European Commission. Includes the full text of EU Regulation on Devices Using Animal Tissues.
The EU Network for Health Technology Assessment (EUnetHTA) recommends that nine key domains be considered in evaluating medical screening technologies, according to a draft document released Sept. 27.
Both manufacturers and importers must report device-related incidents to Health Canada, unless the devicemaker authorizes the importer in writing to report on the manufacturer’s behalf, according to final guidance on mandatory problem reporting for medical devices.
Starting Nov. 1, makers of Class III and IV devices and in vitro diagnostics (IVDs) must submit all premarket review documents to Health Canada in both paper and electronic formats, an Oct. 19 guidance states.
EU medical device industry association Eucomed says it will no longer support third-party educational conferences focusing more on marketing than on science.
Device-related adverse incidents rose 13 percent to 10,280 in the UK during 2010, according to the Medicines and Healthcare Regulatory products Agency (MHRA).
Device companies are solidly united against an Institute of Medicine (IOM) recommendation that the U.S. Food and Drug Administration (FDA) discard the 510(k).
U.S. oversight of medical devices, including harmonization with other nations’ device regulatory programs, would change dramatically under bills introduced last week by members of the House Energy and Commerce Committee.
A new U.S. Senate bill to spur device innovation would bar U.S. Food and Drug Administration (FDA) staff from pursuing marginal lines of questioning during device reviews.
By pushing inspector training and reemphasizing a directive that investigators focus during inspections on two facility systems, the U.S. Food and Drug Administration (FDA) hopes to do a better job of inspecting device and other facilities.
Metal-on-metal (MoM) hip implants pose risks that don’t outweigh their benefits, says the U.S.-based California Technology Assessment Forum (CTAF).
Mandatory training, more use of implants that are safe to undergo magnetic resonance imaging (MRI) and better adherence to agency guidance could decrease the incidence of MRI accidents, participants at a U.S. Food and Drug Administration workshop said.
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