The system will allow healthcare professionals to reuse the critical care products up to 20 times during the COVID-19 pandemic.
Sources of reliable data to continuously support claims of compliance by manufacturers will be in high demand in the future.
The agency has altered its import screening to accelerate the availability of PPEs.
The more devices are connected, the more that targets are present for remote attackers.
The agency will continue to work with companies developing diagnostics relevant to the coronavirus outbreak in an effort to rapidly bring technologies to market.
Due to the public health emergency, the agency is implementing the guidance document immediately, without public comment.
Both paper and digital paper are outdated approaches to medical device quality management.
Recalls for failure are chronic in the medical device industry. The sources of those failures could originate anywhere in the supply chain. Fixing supply chain issues is ultimately the responsibility of the instrument’s maker.
The enforcement operation kept nearly 500 shipments of illegal drugs and combination devices from the hands of consumers.
FDA, CDC and other agencies are trying to foster the development of diagnostics, therapeutics and vaccines that help address the outbreak.