December 4, 2017 – The U.S. Food and Drug Administration (FDA) on December 4 released a new set of recommendations for creating medical products using 3D printers. The guidance details the agency’s stance on device design, testing, and quality system requirements.
For a relatively new technology, 3D printing has a wide range of clinical applications, such as building functionally accurate replicas of complex anatomical structures and facilitating surgery simulations to restore hearing loss, remove stroke clots, and repair hip disorders. The rapid evolution of this technique has led the FDA to release an early policy framework to help manufacturers bring 3D-printed models to the market more efficiently.
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1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement, which updates the agreement from 1998, allows for recognition of each other’s inspection outcomes and hence for better use of inspection expertise and resources.
In June, the European Commission confirmed that the US Food and Drug Administration (FDA) has the capability, capacity and procedures in placeExternal link icon to carry out good manufacturing practice (GMP) inspections at a level equivalent to the EU. Today, the FDA confirmed the capability of eight EU Member States (Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom). The remaining inspectorates will continue to be assessed until 15 July 2019.
Click here for more… (EMA)
Today, machine learning powers more and more medical device software. And because it is always learning and improving, it is constantly changing products on the fly.
For most regulators, an ever-changing algorithm is their worst nightmare. But Bakul Patel is one of those rare Washington bureaucrats who’s also a fervently optimistic futurist. And he’s got big plans to get federal regulators off Washington time and up to Silicon Valley speeds.
To do that, the FDA is creating a new unit dedicated strictly to digital health. Patel will be hiring 13 engineers—software developers, AI experts, cloud computing whizzes—to prepare his agency to regulate a future in which health care is increasingly mediated by machines. Click here for more… (WIRED)