FDA Pushes Device Surveillance Plan That Could Involve PCORI; Off-Label, Data Access Debated-InsideHealthPolicy.com:
FDA device officials are pushing for a national postmarket surveillance monitoring system that emphasizes Unique Device Identifiers and their incorporation into electronic health records, device registries, modernized adverse event reporting and new methods to analyze postmarket information, laying out the plan in a paper released late last week and discussed at a public meeting Monday (Sept. 10).
