Posted 06 September 2017
By Zachary Brennan
Details of how the US Food and Drug Administration (FDA) is planning to tackle the growing digital health industry are slowly trickling out, and on Wednesday the agency announced it will establish an Entrepreneur-in-Residence (EIR) Program to support and help develop its Software Precertification (PreCert) Pilot Program.
The idea is to embed these entrepreneurs for a minimum of three days per week on FDA’s White Oak campus to help analyze software business processes, develop models for data collection and collaborate on new requirements and input.
FDA says it’s looking for software design and business metrics experts, as well as clinical trial designers, among others, to participate in the residence program, which will last a minimum of six months and a maximum of two years (participation will not result in a permanent federal position).
Candidates should apply before 29 September 2017.
The program is part of a larger pilot to pre-certify software-based medical devices, first announced in July. FDA says it plans to select up to nine companies to participate in the voluntary program beginning this month.
Digital Health Entrepreneur-in-Residence Program