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The U.S. Ninth Circuit Court of Appeals has ruled that a whistleblower lawsuit alleging that Medtronic fraudulently obtained a 510(k) from the FDA can proceed, but it dismissed separate off-label promotion claims. Read More
The European Commission’s Medical Device Coordination Group issued guidance for devicemakers of high-risk Class D in vitro diagnostics on applications during the transition period for the EU Invitro Diagnostic Regulation (IVDR) which will go into effect on May 26, 2022. Read More
Examples of custom-made devices include dental crowns, or a prosthesis intended to replace a lost body part or function where the physician provides patient-specific design characteristics necessary for the manufacturing of the device, the MDCG said. Read More
Once a product is on the authorized list, companies must notify the agency at least five business days before they import a designated device. Read More
MedTech Europe noted that any joint EU clinical assessment “must have a clear purpose and their results must also enable appropriate real-life funding or reimbursement decisions taken within member states.” Read More
Devicemakers will need to submit applications to the TGA to show that risk mitigation strategies are in place and that the IVDs comply with performance requirements. Read More
The European Commission’s Medical Device Coordination Group (MDCG) released a Q&A document to help answer questions relating to custom-made devices covered under the EU Medical Device Regulation (MDR). Read More
EU member states have agreed to start negotiations on a proposal that could lead to joint health technology assessments (HTAs) in the bloc, but MedTech Europe and the European Federation of Pharmaceutical Industries and Associations (EFPIA) are worried about some elements of the proposal. Read More
Australia’s Therapeutic Goods Administration (TGA) has outlined its expectations for developers of in vitro diagnostic (IVD) self-tests for infectious diseases like influenza, hepatitis B and hepatitis C, chlamydia, gonorrhea and syphilis. Read More
The FDA said it is investigating numerous medical device reports (MDRs) of patient infections and contamination associated with reprocessed urological endoscopes, including three reported deaths outside the United States. Read More
China’s National Medical Products Administration will allow “versatile” clinical evidence to demonstrate safety and effectiveness, according to attorneys at the law firm Ropes & Gray. Read More