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Eurofins Export Services Oy of Finland has become the 20th notified body designated to certify device products in compliance with the EU Medical Device Regulation (MDR). Read More
A federal judge has issued a preliminary injunction blocking Charles River Laboratories (CRL) from harvesting the blood of horseshoe crabs for use in bacterial contamination tests for drugs and vaccines — a move that could lead to a shortage of the much-needed tests. Read More
The European Commission has proposed stiffer regulations for products that rely on artificial intelligence (AI) and some medical devices would be considered “high risk” under the proposal. Read More
Several House Democrats have urged the Department of Health and Human Services (HHS) to reverse a Trump administration policy that removed FDA premarket review requirements for COVID-19 laboratory-developed tests (LDTs). Read More
The FDA issued new recommendations on 510(k) submissions for peripheral vascular atherectomy devices used to remove plaque from diseased arteries. Read More
May 26 marks the effective date of the EU’s Medical Device Regulation (MDR), requiring new devices to comply before they can be sold in the bloc — although many currently certified devices have another three years to comply. Read More
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