 
August, 2023
Discover how the Digital Health Center of Excellence (DHCoE) at the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is leading the advancement of digital health to protect and promote public health.
DHCoE Activities
Announced Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing
The FDA and Product Quality Research Institute (PQRI) are excited to announce they will host an FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing on September 26 – 27, 2023, as a virtual event.
This FDA/PQRI Workshop will bring together leaders from regulatory agencies, industry, and academia to discuss critical topics related to the use of artificial intelligence (AI) in pharmaceutical manufacturing. View Workshop Details.
|
Issued Final Guidance and Hosted Webinar for Content of Premarket Submissions for Device Software Functions
On June 13, 2023, the FDA issued the final guidance Content of Premarket Submissions for Device Software Functions. The final guidance provides information regarding the recommended documentation sponsors should include in premarket submissions for the FDA’s evaluation of the safety and effectiveness of device software functions. This final guidance fulfills an FDA commitment in MDUFA V and is intended to provide clarity, simplicity, and harmonization with current best practices and recognized voluntary consensus standards.
On July 20, 2023, the FDA held a webinar for industry and other interested stakeholders to discuss the final guidance. View the Webinar. Read the Transcript.
|
Launched the Veterans Cardiac Health and AI Model Predictions (V-CHAMPS) Challenge
On May 25, 2023, the Veterans Health Administration Innovation Ecosystem, the Digital Health Center of Excellence at the FDA, the FDA Office of Digital Transformation's precisionFDA, and the UK Medicines and Healthcare products Regulatory Agency called on the scientific and data analytics community to develop and evaluate Artificial Intelligence and Machine Learning (AI/ML) models to predict cardiovascular health related outcomes in veterans. View the Challenge.
|
Released the discussion paper Using Artificial Intelligence (AI) and Machine Learning (ML) in the Development of Drug and Biological Products
As with other evolving fields of science and technology, there are challenges associated with AI/ML in drug development, such as ethical and security considerations like improper data sharing or cybersecurity risks. There are also concerns with using algorithms that have a degree of opacity, or algorithms that may have internal operations that are not visible to users or other interested parties. This can lead to amplification of errors or preexisting biases in the data.
|
Issued Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development
On March 23, 2023, the FDA released a framework, titled Framework for the Use of DHTs in Drug and Biological Product Development. This document outlines the Framework that the FDA will use to implement a multifaceted DHT program for drugs. The program will include workshops and demonstration projects; engagement with stakeholders; establishment of internal processes to support the evaluation of DHTs for use in drug development; promotion of shared learning and consistency regarding DHT-based policy, procedure, and analytic tool development; and publication of guidance documents.
|
We Are Hiring!
 |
|
We are continuing to build a dynamic team who is at the forefront of advancing medical science, creating new opportunities, and a regulatory environment that brings safe and effective digital health technologies to market. If you are interested in applying to one of the following open positions, submit an electronic resume or curriculum vitae, cover letter containing a brief summary of accomplishments, SF-50 (if applicable), and a copy of unofficial transcripts all in one document (Adobe PDF) to DigitalHealth@fda.hhs.gov. |
Open Positions
Digital Health Advisor
Seeking experts responsible for drafting, implementing, supporting, and furthering practices and policies that foster high quality digital health technologies throughout the total product lifecycle. Candidates with modern software development and delivery experience designing technology solutions and high-quality software and hardware platforms for healthcare and medical devices industries with specialties in areas such as Extended Reality (XR), medical device interoperability, or In Vitro Diagnostics (IVD), to name a few, are encouraged to apply. Read the job description.
Physician
Seeking a physician with expertise in digital health who will provide clinical leadership and technical advisement for digital health regulatory policy development, medical product review, regulatory science research activities, clinical investigations, and partnership development. Candidates in all medical fields encouraged to apply. Read the job description.
Contact CDRH’s Digital Health Center of Excellence
We help our stakeholders navigate the FDA's current policies on digital health products and provided informal feedback on the possible regulatory status of products in development. Please reach out to us with your questions!
-
For questions about digital health regulatory policies, visit our website for helpful information and more on how to contact us.
-
For general DHCoE questions, please email DigitalHealth@fda.hhs.gov.
|
