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 UK National Institute for Health Research (NIHR) has launched on its website an interactive medtech "study start-up" route map to assist device companies intending to sponsor and fund clinical research studies involving patients in the National ...
How successful have the EU member states been in implementing the revision of the medical device directives into national law? And has this been done in a harmonised way? Alexandre Regniault and colleagues* report on variations that have resulted ...
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 ...
The search functionality of Australia's online register of approved devices and drugs has been improved to enable industry, health professionals and consumers to find information on products more easily 1 ,2 . Changes to the Australian Register of ...
US medtech industry association AdvaMed is concerned about the US Food and Drug Administration ’s draft guidance on presenting risk information while promoting medical products because it is too heavily focused on prescription drugs 1 . The guidance ...
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The US Food and Drug Administration is seeking feedback on a draft guidance on tests that will enable medical device manufacturers to understand and optimise how people interact with technology, thereby helping them improve the safety and ...
