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The House passed by voice vote its version of the FDA user fee reauthorization package Wednesday, which includes an updated version of MDUFA expected to bring in $183 million in fiscal 2018. Read More
The project will focus on modernizing the agency’s regulatory processes and reducing the time, cost and uncertainty of bringing a product to market. Read More
Both houses of Australia’s Parliament passed a new law to amend the Therapeutic Goods Act 1989 to enable certain variations that do not impact quality, safety or efficacy to be made by notification to the Therapeutic Goods Administration. Read More
As of June 1, South Africa has its first regulatory system for medical devices and in vitro diagnostics, which will include new quality management requirements. Read More
Following a spate of superbug outbreaks and deaths from contaminated duodenoscopes and similar devices, the FDA will soon have tougher validation requirements for certain new devices. Read More
The Dutch medical device authority has reached a voluntary agreement with industry on the use of UDI codes for medical devices, using FDA’s UDI system as a template. Read More
Devicemakers are closely watching the EMA and the U.K.’s Medicines and Healthcare products Regulatory Agency for assurances on how conformity assessments will unfold under the new EU regulations. With fewer notified bodies in the EU, and the added complication of Brexit, the next steps remain uncertain. Qserve Group Executive Director Gert Bos — an auditor and former head of a notified body — spoke with IDDM on the changing environment and how devicemakers can plan for upcoming conformity assessments. Read More