Third party review pilot staggers forward:
This article was originally published in Clinica
The Office of Device Evaluation's two-year voluntary programme of third party review for low and moderate risk products is to be expanded in 1998, despite having attracted only five submissions to date. Guidance for 16 of the 30 classes of device included in the pilot is now available, and the remaining device categories will be covered by the end of May. In 1998, said Susan Alpert, head of the ODE, as many as 30 more categories of device could be added to the pilot.