International Medical Device Regulatory Monitor

EU lawmakers seemed lukewarm, at best, on the idea of subjecting the riskiest medical devices to a U.S.-style premarket approval mechanism during a May 29 debate by members of the Committee on the Environment, Public Health and Food Safety.

Six years after the EU’s advanced therapy medicinal products regulation went into effect, only one tissue-engineered product has been granted approval, Eucomed says in comments criticizing the regulation’s approach to the evaluation of ATMP products.

Beginning this month, devicemakers in France must begin reporting all payments and other benefits to healthcare professionals in excess of €10, including tax — about US $12.87.

The UK’s Medicines and Healthcare products Regulatory Agency is seeking views on its approach to implementing the European Commission’s regulations on use of animal tissues in medical devices and electronic labeling.

The European Commission is seeking input from its scientific committees on the relationship of synthetic biology (SB) to the genetic modification of organisms, its implications for human health and the major gaps in knowledge necessary for performing a reliable risk assessment.

The UK’s National Institute for Health and Clinical Excellence on May 1 took over the National Health Systems’ technology adoption program, ensuring a “more seamless and effective route” to the adoption of novel diagnostics, surgical implants and other devices.

The China Food and Drug Administration last month released a document outlining acceptance criteria for in vitro diagnostic reagents makers.

Australia’s Therapeutic Goods Administration is recommending to move forward with a proposal that would increase the number of mandatory audits for high-risk devices, make transparent all device regulatory decisions and allow all but Class IV in vitro diagnostic devicemakers to use non-TGA conformity assessments.

Australian devicemakers are calling for a more flexible clinical trials cost structure to allow for variations in disease states and different types of devices.

The prospect of a standardized single audit program for medical devices, currently being developed by the International Medical Device Regulators Forum, is fueling efforts by Brazil’s Anvisa to bring device good manufacturing practice regulations in line with international standards, an expert says.

Medical devices place a smaller burden on healthcare costs and are more affordable relative to gross domestic product in Canada compared with most other countries, according to a new study of device spending in 66 countries.

The U.S. Food and Drug Administration’s proposed rule on use of overseas clinical trial data for devices should not apply informed consent provisions to in vitro diagnostic studies that use de-identified samples, Roche says in comments to the rule.

Oral arguments in a case challenging the U.S. Securities and Exchange Commission’s (SEC) conflict minerals rule have been delayed after a ruling in a separate case showed the challenge needed to be moved to the U.S. District Court for the District of Columbia.