Data Control Key In Applying Electronic Health Records As Clinical Trial Tool, FDA Says
Newly finalized guidance from US FDA details the agency's considerations for device and drug sponsors to rely on electronic health records as a clinical trial data source.
You may also be interested in...
Two months into the job, Medical Device Innovation Consortium CEO Pamela Goldberg talks about the organization's work running the NEST Coordinating Center, its efforts to engage the Medicare agency, early feasibility studies and its work with US FDA on Case for Quality.
Clinical trial sponsors are free to use any electronic health record system that meets FDA standards to collect clinical trial data, but the agency recommends use of Office of the National Coordinator for Health Information Technology-certified systems to better ensure that the EHR meets requirements for interoperability, reliability and confidentiality.
The US agency sent a letter to health-care providers spotlighting its analysis of the increasing numbers of adverse events linked to surgical staplers and implantable staples, and its plans for a draft guidance on labeling and an advisory panel meeting to consider a 510(k) requirement for the products.