The agency recently released a guidance document that gives device manufacturers an optional pathway to make certain modifications to their device.
The company developed the device as an alternative to reusable duodenoscopes, enabling the use of a new and sterile product for each procedure.
The agency’s move is a win for early screening of a rare genetic disorder, which leads to progressive muscle deterioration.
CooperVision, Inc. and Pentax of America won the agency approvals, respectively.
URGENT/11 introduces risks to medical device and hospital networks, and could allow a remote attacker to take control of a medical device such as an anesthesia machine of insulin pump.
Will more medical devices be impacted?
OPEQ is an important step in the center’s modernization of business processes.
This new pathway is a considerable change for the medical device industry.
The center will start phasing in efficiencies on March 18.
According to the FDA, more than 90% of products sterilized at the facility are medical devices.