CDRH is looking for entrepreneurs to help the agency create digital health regulations.
The Entrepreneur-in-Residence program is meant to help develop the FDA’s Software Precertification pilot program announced in August. PreCert is a cornerstone of the agency’s Digital Health Innovation Action Plan. It will enable the FDA to develop a “tailored approach” for regulating software as a medical device.
EIR fellows must have at least five years of work experience in software design, clinical trial design, post-market surveillance, or the use of real-world evidence, to qualify for a temporary position in the program. The fellows will work at least three days each week at the FDA’s White Oak campus, where they will analyze software business processes, develop and test data collection models; and identify ways to improve processes and policies on data sharing and access. The agency is hiring for six positions, spokesperson Stephanie Caccomo told FDAnews.
The deadline for applications is Sept. 29, 2017.