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 US Food and Drug Administration is planning to hold a public hearing on issues that would help advance the development of medical products, including medical devices, drugs and biologics, used in the prevention, diagnosis and treatment of ...
The US Association for the Advancement of Medical Instrumentation has created a new working group that will focus on gaps in existing standards of bio-absorbable vascular implants, such as coronary stents 1 . The group has been created to complement ...
With devices becoming increasingly complex, competent authorities in the European Union must ensure there are sufficiently well-trained experts at notified body level, particularly for assessing innovative devices and for clinical trials. But ...
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 ...
TÜV Product Service , one the main notified bodies for medical devices in the European Union, is in no doubt that the basic EU medtech regulatory structure is sound. But as work is being carried out to improve standards among notified bodies, the ...
Health Canada has been asked to consider expanding the scope of medical devices currently covered under its transparency initiative, under which the regulator posts an online summary of the aspects it has considered when granting marketing ...
The Asian Harmonization Working Party agreed six criteria for a medical device nomenclature system at its 14th meeting in Hong Kong on 4-7 November 2009 1 . The requirements ‒ which will help in the selection of a nomenclature system service ...
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 ...
