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New draft guidance recommends how manufacturers can share information generated by devices with patients when they request it.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.
FDA’s perspective on human factors and usability engineering has evolved.