Seven Accredited Bodies Recognized By FDA For 510(k) Third-Party Program
This article was originally published in The Gray Sheet
Executive SummaryFDA has deemed seven organizations eligible for participation in its "Accredited Persons" third-party review program. These seven may start accepting 510(k)s for devices that qualify for the program on Nov. 21, the day the program is mandated to begin under the FDA Modernization Act.
You may also be interested in...
Pharma sells the rights to Germany’s Cheplapharm, which obtained EU/Russia rights in October. Cerecor will acquire Aevi Genomics for $16.1m plus contingent value rights.
Revised bill released by the US Senate Finance Committee adjusts the manufacturer discount program in Medicare Part D and includes new provisions aimed at easing beneficiary cost sharing obligations.
Through a draft guidance, the US agency has established performance criteria for magnetic resonance coils, making the devices eligible for the standards-based Safety and Performance Based Pathway.