Coming days after AdvaMed, MITA detail PreCert recommendations . . .

FDA To Hire Entrepreneurs-In-Residence To Help Develop PreCert Software Program

September 6, 2017 at 4:18 PM
FDA announced Wednesday (Sept. 6) it is hiring Entrepreneurs-In-Residence with backgrounds in software design, business process modeling, clinical trial design and investment to help develop the agency's Software Precertification (PreCert) Pilot Program -- including identifying reliable predictors of product quality, and developing data collection models. One industry attorney tells Inside Health Policy that FDA typically uses EIRs when evaluating new technologies, and praised FDA's decision to hire these experts to aid in the agency's rethink of how to...


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