The Food and Drug Administration (FDA), in conjunction with its Center for Devices and Radiological Health arm, is ramping up medical app and device offerings with its recently announced digital health unit.
The aim of this development is to centralize and coordinate digital health information so that there is consistency in applying policies. According to the associate director of digital health for the FDA, Bakul Patel, the primary responsibilities of those on the project will be to develop software and digital health tech to assist with premarket submissions or devices, utilize experts, and incorporate metrics that will assist with review times and submission.
Over the past few years, the agency has taken numerous, albeit tentative, steps into the realm of digital health, including guidelines for wellness app last year and cybersecurity guidelines for medical devices.
Beginning October 1, 2017, the agency will begin the hiring of 13 full-time employees from various private sectors with hopes of having them on board by the 2018 fiscal year. But, as HealthData Management reports, some are pessimistic about the long-term outcomes of these new hires citing Bradley Merrill Thompson, a lawyer in Washington D.C., who expresses some concern and told the organization:
“Right now salaries for people in those domains are sky-high, and that means many folks are very nervous about how FDA will succeed in recruiting the talent it needs … For example, machine learning is a key knowledge base that FDA should have going forward, but machine learning people are in extremely scarce supply.”
