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.
Last year the agency surpassed a 40-year record set in 2017, approving 106 novel devices.
The agency will be improving postmarket surveillance, looking at issues that come up once a device is on the market, and promoting innovation.