FDA has published a detailed draft guidance to assist sponsors with the codevelopment of IVD and Therapeutics. The guidance offers detailed advice on development principles, regulatory requirements and administrative issues for the development of companion IVD devices alongside the therapeutic goods and gives the opportunity for industry to comment and suggest improvements to this process.
Archives for August 2016
Joint Chinese agencies have released the ruling for the China ROHs 2.0, Restriction of hazardous substance in Electrical & electronic products effective 1st July, 2016. A product list for mandatory compliance will be published shortly. In summary, products listed that contain specific Hazardous substances must be below the prescribed limitations, however products not included in this mandatory compliance list may exceed the limits if they comply with the required labeling.