FDA Flips the Switch on Pelvic Mesh Manufacturers
FDA has ordered Boston Scientific and Coloplast to stop selling surgical mesh intended for transvaginal repair of pelvic organ prolapse. Patient advocates say the action was not made soon enough and does not go far enough, but it is a step in the right direction.
Dirty Scopes Are Still a Big Problem
FDA-mandated studies indicate higher than expected levels of contamination on duodenoscopes after reprocessing.
Taking a Deeper Look at Device Certification and Recertification
Experts discuss how to prioritize medical and IVD devices under the new MDR/IVDR in Europe.
Key Medical Packaging Standard, ISO 11607-1/2 Published; More Regulatory Support on the Way
With the EU Medical Device Regulations just over one year away, this latest revision aims to help medical device manufacturers meet the regulation’s General Safety and Performance Requirements.
SO 80369: Frequently Asked Questions, Answered
Here are answers to some common questions about developing and testing small-bore connectors.
Considering Old and New 510(k) Predicates
span style=”font-weight:normal;”>Is a new device necessarily better?
Another Reason to Update Your Biocompatibility Approach: EU MDRs
A chemist and biocompatibility expert offers the latest insights and predictions on medtech biocompatibility testing.
How Is the Government Shutdown Impacting Medtech?
FDA cannot accept new 2019 user fees during the government shutdown, which means the agency cannot accept new medical product applications.
Essure Discontinuation Doesn’t Mean the End to FDA Scrutiny
Bayer has already decided to stop selling the controversial birth control device, but FDA says it will continue to monitor the long-term safety of Essure.
Is Progress on MDR and IVDR Happening Fast Enough?
One year into the transition periods for the new EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), industry experts continue to express concern that more progress is needed to help companies prepare for the new regulations within the limited transition period.
