FDA to Create Digital Health Unit Regulating Medical Devices
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Jeremy Barbera shares a presentation on how the digital health unit will be created by the FDA
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FDA to Create Digital Health Unit Regulating Medical Devices
- 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.