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Testing is important because of electromagnetic interference risks both from the magnetic resonance system as well as the sensitivity of MR systems to radiofrequency noise from active devices, the agency said. 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
AdvaMed is urging the Centers for Medicare and Medicaid to implement the Medicare Coverage of Innovative Technology (MCIT) rule without delay after CMS announced it would postpone a final ruling on the regulation that would provide immediate national coverage for four years for any new device or diagnostic designated as a breakthrough technology. 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 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