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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
The FDA has revised a previous draft on its current approach to conducting remote regulatory assessments (RRA), incorporating public comments as well as recent amendments to the Food, Drug and Cosmetic Act. Read More
Over the past week, the FDA issued final guidance on revising ANDA labeling, draft guidances on metallic coatings and/or calcium phosphate coatings on orthopedic devices and conducting remote regulatory assessments. The agency also announced a meeting of the circulatory system devices panel of the medical devices advisory committee and posted best practices for FDA staff in postmarketing safety surveillance. 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The FDA’s newest draft guidance addresses premarket submission requirements for Class II and III implantable orthopedic devices coated with metals, calcium phosphate, or a combination of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
This edition of Quick Notes looks at the FDA approving devices and systems that detect and/or offer treatment for potential skin cancer, Alzheimer’s, lung fibrosis and diabetic neuropathy. Read More