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The FDA has reversed a Trump Administration policy that was set to exempt 83 class II devices and one unclassified device from premarket notification requirements. Read More
The Philippines Food and Drug Administration issued draft guidelines on its new eServices Portal System for medical devicemakers and distributors to help them transition their license to operate (LTO) applications. Read More
The European Commission is calling on EU standardization groups to revise more than 200 existing harmonized standards and to draft 27 new standards over the next three years in support of the EU’s Medical Device Regulation and In Vitro Device Regulation. Read More
The FDA has issued five new warning letters this month related to misbranded and adulterated COVID-19 tests, as the agency continues to urgently target manufacturers and suppliers of unapproved COVID-19 products. Read More
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