The FDA will be creating a new centralized Digital Health Unit within its Center for Devices and Radiological Health in order to regulate medical devices and technologies more effectively. This unit will develop standards and metrics for reviewing software and devices before they are available to the public. Additionally, it will track and evaluate submissions to maintain consistency in policy. As digital health is a new area for the FDA, it plans to hire experts from outside the agency rather than training staff internally, in order to supplement the FDA's expertise in complex areas like AI and cybersecurity. However, retention is a concern given the high salaries in these fields and that the experience could make young professionals more likely to leave for other opportunities.

1. Digital Health Unit to be Created by
the FDA

2. The Food and Drug Administration
(FDA) has recently announced that
they will be allocated funds and
resources to a new centralized unit
focusing on mostly on regulating
medical devices.

3. This unit will be a branch within the
Center for Devices and Radiological
Health.

4. The goal of this unit, in conjunction
with its larger department, is to
basically maintain a certain level of
consistency when it comes to
applying effective health policies.

5. The functions of this digital health
unit range has two main areas
which are outlined below:

6. Creating software and developing assistance
programs for software as medical devices or
other digital health technologies before they
reach the public.
Integrating useful metrics to track, evaluate
and report pre-market health submissions.

7. In order to diversify the efficiency throughout
this new centralized digital health unit, the
FDA has confirmed that the agency will be
hiring experts from the private sector instead
of bringing in talent internally.

8. “The world of digital health has a lot of
expertise that we need to supplement our
organization with,” Bakul Patel, associate
director of digital health in the FDA’s CDRH
states. “If we had to do it all internally, then it
would defeat the purpose.”

9. However, it will be quite difficult to hire
professionals with particular expertise in
complex areas such as artificial intelligence,
cloud computing and cybersecurity. While the
salaries for these types of positions are quite
high, Patel is hesitant with regard to hiring
fresh, young talent right of college.

10. In other words, retention an area of concern
within the FDA recruitment process He is
aware that this type of position at the FDA is an
experience booster, making these young
professionals even more marketable, leading
them to leave within a few years for another
opportunity.

11. In this competitive market, it is possible that
the above factors will make it hard for even new
centralized health units to retain talent when
there are a wide spectrum of incoming
opportunities in the private and public sectors.