FDA said interim results from sampling studies indicate higher-than-expected contamination rates after reprocessing of duodenoscopes currently on the market.
Regulatory and Compliance
Olympus agreed to pay $85 million to settle a federal investigation of its that began in 2015. A former executive also pleaded guilty and faces up to a year in prison.
FDA proposed a new rule that, if finalized, could motivate more companies to choose the de novo pathway for new devices that do not have a modern predicate.
The EU regulation may have been around for more than a decade, but there is still a lot for medtech to learn.
From 2015 through 2018, about 20% of 510(k) clearances were based on substantial equivalence to a predicate device that was more than a decade old. Should FDA continue to allow this practice, or should older devices be retired as predicates?
A medical device supplier is recalling certain lots of its temporary bipolar pacing leads that are used in conjunction with a compatible external pulse generator for the temporary pacing and sensing of the heart.
Zimmer Biomet initiated the recall due to the lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue.
FDA is taking what it calls "transformative new steps" to modernize the agency's 510(k) program to keep pace with the increasing complexity of rapidly evolving medical technology.
AdvaMed has taken issue with the investigative report, arguing that it fails to look at both the challenges and the accomplishments of the medical device industry.
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.
The recall was prompted by an incident in which the top detector of a Millennium Nuclear Medical System detached and fell onto the detector below.