The goal of the guidance is to ensure that manufacturers are prepared to report adverse events during a pandemic.
Due to the public health emergency, the agency is implementing the guidance document immediately, without public comment.
Special controls are also provided for reasonable assurance of the safety and effectiveness of the devices impacted by the reclassification.
Designers and manufacturers of both devices and software must conduct due diligence and ensure regulatory compliance in protecting user data.
The agency recently released a guidance document that gives device manufacturers an optional pathway to make certain modifications to their device.
Manufacturers finally have some clarity on which CGMP requirements apply when producing a combination product.
The final guidance is part of the agency’s effort to provide better patient access to new devices via stronger and streamlined clinical trials.
The agency released a guidance document with product design recommendations to help prevent contamination from device components.
New draft guidance recommends how manufacturers can share information generated by devices with patients when they request it.
From human factors to laboratory developed tests to medical device reporting, CDRH has ambitious plans for 2016.