We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA details its expectations for postmarket surveillance of moderate and high-risk devices in two draft guidances, including its criteria for ordering postmarket data collection. Read More
The FDA has studied how South Korea handled authorizations of COVID-19 diagnostic tests, hoping to learn from that country’s early success in dealing with the virus. Read More
The FDA has studied how South Korea handled authorizations of COVID-19 diagnostic tests, hoping to learn from that country’s early success in dealing with the virus. Read More
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
The European Commission has launched an online helpdesk for devicemakers who must comply with the new unique device identification (UDI) system introduced under the EU Medical Device Regulation (MDR), which went into effect on May 26. 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
May 26 marked 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
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
Developers need to consider electrical safety and electromagnetic compatibility, because the implanted devices may expose the operator and patient to electrical energy hazards, the agency said. Read More