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The Center for Devices and Radiologic Health may not meet its Medical Device User Fee Act (MDUFA) review goals during the pandemic, two senior officials warned. Read More
The FDA issued a final rule that updates the descriptions of eight software functions that don’t meet the definition of medical device under the 21st Century Cures Act, effectively removing certain software from regulation. 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
The FDA issued five new warning letters last 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 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 announced that it will conclude its Quality in 510(k) Review Program pilot after May 30 and will no longer accept submissions after that date, directing companies to consider using its electronic Submission Template and Resource (eSTAR) pilot program instead. Read More
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
Adverse events reported in MAUDE alone are an inappropriate basis for exemptions because adverse events may be under reported for certain devices and may not necessarily reflect the risk of injury, the agency noted. Read More
The standards should include detailed technical specifications in relation to the requirements set out in the new EU regulations, the commission said. Read More
Operation Quack Hack includes a team of consumer safety officers, special agents and intelligence analysts who triage incoming complaints about fraudulent and unproven medical products. Read More
Establishing the EU reference laboratories (EURLs) for a range of Class D devices has been identified as an important priority and the European Commission is working on introducing the criteria and fees for the EURLs. Read More