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During its second town hall on reducing the use of ethylene oxide (EtO) to sterilize medical devices, FDA officials announced the creation of a dedicated EtO “tiger team” with expertise in regulatory science, regulatory review, policy, supply chain, and incident response. Read More
In a move that caught many industry experts unaware, the U.S. government last week announced the sale of the Federal Helium Reserve to a private company, despite warnings about the risk of shortage for critical helium that powers magnetic resonance imaging (MRI) machines. Read More
Philips Respironics announced that it has agreed to the terms of a consent decree which will require it to cease the sale of new CPAP or BiPAP sleep therapy devices or other respiratory care devices in the U.S. Read More
In the face of inveterate manufacturer foot-dragging and a dearth of certified review bodies, the European Commission (EC) is once again proposing to extend the deadline for companies to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR). Read More
The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SME) in the pharmaceutical sector, including updates to reflect new EU regulations, guidance for working with technology and data and collaborating outside the EU. Read More
The FDA’s newest draft guidance addresses premarket submission requirements for Class II and III implantable orthopedic devices coated with metals, calcium phosphate, or a combination of those materials. Read More
CMS and the FDA have issued a rare joint statement advocating for the oversight of laboratory developed tests (LDT) by both agencies, rather than keeping it solely within CMS. Read More
Inspections will be much more streamlined once the FDA completes its sweeping reorganization, according to Deputy Commissioner Janet Woodcock. Read More