The US Food and Drug Administration has reopened until 7 September the public comment period for its proposal to lower the classification of certain neurological and physical medicine devices from Class III (high-risk) to Class II (medium-risk) 1,2 ...
The UK Medicines and Healthcare products Regulatory Agency plans to begin a pilot programme in September that could lead to the development of a medical device driving licence (MDDL) for certifying the proficiency of healthcare workers in handling ...
The US Food and Drug Administration and the Federal Communications Commission have formed an initiative to improve the efficiency of their respective regulatory processes applicable to broadband and wireless-enabled medical devices 1 . The agencies ...
A non-governmental organisation has published guidance that it says will give companies a "head-start" in meeting the challenges of complying with the provisions of the UK Bribery Act, which comes into force in April 2011 1-3 . Transparency ...
A legal petition by the US Food and Drug Administration to regulate electronic cigarettes as medical devices has come under criticism by the Washington Legal Foundation, a public interest law and policy centre 1 ,2 . E-cigarettes are not medical ...
The UK government plans to cut the number of health-related agency bodies from 18 to between just eight and ten, as part of an exercise to streamline the organisations and deliver savings of over £180m (US$279 million) by 2014-15 1 ,2 . Its move ...
The Human Tissues Working Party of UK charity the Safer Medicines Trust believes that individuals on the organ donor register should be asked about the possibility of donating tissues that would be removed solely for use in research (ie not for ...
There will be a delay in the appointment of the new executive director at the European Medicines Agency , the European Commission has confirmed to RAJ Devices 1 . A commission spokesperson said: "It is now certain that there will be an interregnum ...
A somatic cell therapy for treating cardiovascular diseases has become the first product to obtain certification of experimental data by the European Medicines Agency under the European Union´s framework for advanced therapy medicinal products 1 ,2 ...
The US Food and Drug Administration has sent warning letters to 13 molecular diagnostic companies as part of its bid to improve the regulation of genetic testing 1 . The agency has targeted firms selling genetic tests directly to consumers, ...
The medtech industry has expressed concern over draft proposals from the US Food and Drug Administration for the agency to disclose to the public information on medical devices and drugs that have not yet been approved 1 . Disclosing information on ...
The Australian health department has issued an order to clarify the classification of certain medical products that do not qualify as medical devices under the current regulations 1 . The Therapeutic Goods (Articles that are not Medical Devices) ...
The UK Bribery Act, which was signed into law earlier this year, will come into force in April 2011, the Ministry of Justice has announced 1 ,2 . Its implementation is expected to pave the way for fairer practice by encouraging companies to adopt ...
The US Food and Drug Administration should, as far as possible, rely on existing standards to achieve the objectives of its "home-use" initiative, which aims to assure the safe use of medical devices in patients' homes, says medtech industry ...
The deputy director of China's State Food and Drug Administration has been dismissed from his position for unspecified suspected "disciplinary violations" 1 . The move follows the initiation of an investigation against the official, Zhang Jingli , ...
The US Supreme Court has ruled that the so-called "machine-or-transformation" test is not the only way to determine the patentability of a new method 1 . The test required a patentable process to be either tied to a machine or apparatus or to ...
An Australian court has admitted a petition challenging the validity of a patent for a human gene (BRCA1) associated with breast cancer 1 ,2 . The case – filed against the three co-owners of the BRCA1 patent (Myriad Genetics, Centre de recherche du ...
The World Health Professions Alliance is calling for stronger action to be taken to stem the counterfeiting of medical products under a new campaign called “Be aware, take action” aimed at the collective of more than 26 million health professionals ...
New legislation has been introduced in the US House of Representatives to grant fee-setting authority to the Patent and Trademark Office 1 ,2 . The bill aims to provide sustainable funding to the PTO that would allow it to better tackle the growing ...
