The time it takes for the US Food and Drug Administration to review 510(k) applications for clearing medical devices has increased because of industry's failure to file submissions of an adequate quality, an internal analysis by the FDA has revealed ...

The US Food and Drug Administration is giving stakeholders another chance to submit comments on factors affecting the reprocessing of reusable medical devices 1 . The FDA has reopened the opportunity to comment after stakeholders were unable to ...

The US Food and Drug Administration is to hold a workshop in which it will seek stakeholder feedback on the adoption, implementation and use of unique device identifiers in various health-related electronic data systems 1 . Implementing UDIs in ...

The US Food Drug Administration is seeking feedback on a procedure that it expects will help its devices unit clarify and communicate to stakeholders more quickly any changes in its regulatory expectations that could affect data submitted as part of ...

Australia's Therapeutic Goods Administration's "should move away from the conservative approach that has characterised its actions in the past and recognise that it has a duty to collaborate with stakeholders to create a culture in which the ...

A broad coalition of US medical technology companies and industry associations is urging Congress to repeal the $20 billion medical device tax that is set to come into effect in 2013 1 . The 2.3% medical device tax, which was passed as a part of the ...

The Irish Medicines Board , having found no takers for a new service it started last year to offer formal scientific advice on the drug component of drug/device combination products, is planning to charge a reduced fee for the job 1 ,2 . Reacting to ...

The Human Fertilisation and Embryology Act 2008 came into force in the UK on 1 October 1 ,2 . The law ensures that all human embryos outside the body – whatever process used in their creation – are subject to regulation, said the Department of ...

The US Food and Drug Administration , responding to concerns over the lack of specific postmarketing safety reporting requirements for combination products, has issued a much-awaited proposed rule to address the issue 1 . In addition to requiring ...

The time it takes for the US Food and Drug Administration to review 510(k) applications for clearing medical devices has increased because of industry's failure to file submissions of an adequate quality, an internal analysis by the FDA has revealed ...

The US Food and Drug Administration is giving stakeholders another chance to submit comments on factors affecting the reprocessing of reusable medical devices 1 . The FDA has reopened the opportunity to comment after stakeholders were unable to ...

The US Food Drug Administration is seeking feedback on a procedure that it expects will help its devices unit clarify and communicate to stakeholders more quickly any changes in its regulatory expectations that could affect data submitted as part of ...

Australia's Therapeutic Goods Administration's "should move away from the conservative approach that has characterised its actions in the past and recognise that it has a duty to collaborate with stakeholders to create a culture in which the ...

The US Food and Drug Administration is to hold a workshop in which it will seek stakeholder feedback on the adoption, implementation and use of unique device identifiers in various health-related electronic data systems 1 . Implementing UDIs in ...

A broad coalition of US medical technology companies and industry associations is urging Congress to repeal the $20 billion medical device tax that is set to come into effect in 2013 1 . The 2.3% medical device tax, which was passed as a part of the ...

The US Food and Drug Administration's procedures for overseeing medical device recalls are unclear and represent a missed opportunity for the agency to proactively identify and address risks presented by unsafe devices, the Government Accountability ...

China's State Food and Drug Administration has promulgated interim provisions relating to its management of the medical device recall process 1 ,2 . The new provisions, comprising six chapters and 38 articles, are due to come into effect on 1 ...

The governments of New Zealand and Australia have agreed on a new trans-Tasman plan to implement a single patent application and examination process for both countries that would provide inventors with a faster, cheaper and more streamlined patent ...

Representatives Harold Rogers (Republican - Kentucky), chairman of the House Appropriations Committee, and Paul Ryan (Republican - Wisconsin), chairman of the House Budget Committee, have raised objections to a measure in the patent reform bill ...

In the latest stage of the long and convoluted journey towards implementing a single EU patent system, the European Parliament's legal affairs committee has voted in favour of allowing a limited number of member states to push ahead with the plan 1 ...

The Belgian presidency of the EU Council of Ministers believes that a compromise can still be reached this year on the translation issues that are holding up agreement on the future EU patent system, even though there is still strong opposition to ...