 
April 10, 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.
Welcome DHCoE’s New Director Troy Tazbaz
CDRH is pleased to announce that on January 30, 2023, Troy Tazbaz joined the FDA as CDRH’s Director of the Digital Health Center of Excellence.
Troy brings to CDRH a wealth of technology industry leadership and management experience, where his contribution as a strategic thought leader will further support our vision for digital health and build upon years of progress.
At CDRH, Troy will lead the DHCoE in its third phase, which is focused on continued growth of strategic partnerships, innovating regulatory frameworks for digital health, and continued harmonization with other regulators. Troy will serve as a strong ambassador for digital health technology and support efforts to take bold steps to embrace responsible innovation that protects patients, addresses bias, advances health equities, and supports a diverse and agile workforce -- all critical for a well-functioning public health ecosystem.
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DHCoE Activities
Promote Consistent Application of Digital Health Policies
Interactive Tools to Help Developers and Manufacturers Develop Digital Health Technologies with Compliance and Regulatory Awareness and Guidance
The FDA's Digital Health Policy Navigator was created to help stakeholders understand the FDA's policies and regulations related to digital health technologies. In December 2022, CDRH’s DHCoE updated the policy navigator to improve access to the tool through the web page and add helpful examples to the clinical decision support software policy considerations. These changes are a result of stakeholder feedback, so please continue to share your feedback with the FDA. View the Digital Health Policy Navigator.
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The Federal Trade Commission’s (FTC) Mobile Health App Tool provides broader context, beyond just the FDA, by helping developers identify which U.S. federal laws may apply to their mobile health app. In December 2022, the FTC, in conjunction with the Health and Human Services Office for Civil Rights (OCR), the Office of the National Coordinator for Health Information Technology (ONC), and the FDA, released an updated version of the tool that reflects regulatory changes that have occurred since the tool's initial launch in 2016. Use the Updated Interactive Tool.
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Newly Recognized Digital Health Standards Can Help Manufacturers Save Time in the Overall Submission Review Process
The FDA regularly updates its Recognized Consensus Standard database, which can help manufactures establish declarations of conformity with their submission. These consensus standards can save time in the device development and FDA review process, meaning products get to market faster. The latest update included eight new digital health-related consensus standards on topics such as cybersecurity, interoperability, and artificial intelligence. Visit the FDA's Recognized Consensus Standards Database.
Advance Equity and Awareness in Health Care
Joint Public Work Encourages the Development of Innovative Medical Devices for Opioid Use
The opioid epidemic is one of the most serious and complex public health problems facing the United States with devastating and far-reaching consequences extending into nearly every community. The FDA and the National Institutes of Health (NIH) remain committed to addressing this national crisis by encouraging and fostering the development of innovative medical devices that protect and promote public health, positively impacting the lives of individuals using opioids.
On November 7-8, 2022, the FDA and NIH hosted a joint public workshop on Medical Devices for Opioid Use with the aim to obtain patients' perspectives on opioid use and opioid use disorder (OUD); to provide a forum for device manufacturers and researchers to discuss challenges related to opioid use; to promote medical device innovation; and to foster informative discussions around health equity that affect people using opioids or living with OUD.
Day 1 Workshop Details. Day 1 Recording.
Day 2 Workshop Details. Day 2 Recording.
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New Interactive List Improves Transparency and Access to Information on Medical Devices that Incorporate Augmented Reality and Virtual Reality (AR/VR)
Augmented Reality and Virtual Reality, or AR/VR, are transforming health care, delivering altogether new types of treatments and diagnostics, and changing how and where care is delivered. As part of our ongoing efforts to advance equity and awareness of digital health technologies used in health care, on December 7, 2022, CDRH DHCoE launched a list of AR/VR medical devices legally marketed in the U.S. CDRH developed this list to increase transparency and access to information on AR/VR medical devices. View the List.
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Lead the Development and Enhancement of New Regulatory Frameworks Tailored to Digital Health Technologies
Congress Passes Bill with Provisions that Foster the Development and Use of Digital Health Technologies to Improve Public Health
In late December 2022, Congress passed, and the President signed, a year-end funding package which includes, among others, provisions for Predetermined Change Control Plans and Clinical Trial Diversity and Modernization:
- A provision for Predetermined Change Control Plans (PCCPs) (section 3308) added section 515C to the FD&C Act, providing the FDA with express authority to approve or clear PCCPs for devices requiring premarket approval or premarket notification. A PCCP describes planned changes that may be made to the device if the device remains safe and effective without any change. Supplemental applications and new premarket notifications are not required for a change to a device that would otherwise require a premarket approval supplement or new premarket notification if the change is consistent with a PCCP previously approved or cleared by the FDA. This provision applies to all devices and is not specific to software or devices with special controls.
- Provisions for Clinical Trial Diversity and Modernization (sections 3601-3607) seek to improve clinical trials by, among other things, increasing diversity and the use of digital health technologies in clinical trials.
Read the Bill.
Draft Guidance Proposes New Approach to Support Iterative Improvement to Machine Learning-enabled Device Software Functions (ML-DSFs)
In alignment with recent legislative changes for Predetermined Change Control Plans (PCCPs), on April 3, 2023, the FDA published draft guidance proposing recommendations on the information to include in a PCCP in a marketing submission for a device that is, or includes, an ML-DSF.
CDRH is committed to advancing health equity as an important focus of our strategic priorities, which affirm that digital health technologies should be designed and targeted to meet the needs of diverse populations. The approach the FDA is proposing in this draft guidance would ensure that important performance considerations, including with respect to race, ethnicity, disease severity, gender, age, and geographical considerations, are addressed in the ongoing development, validation, implementation, and monitoring of AI/ML-enabled devices.
The development and release of this draft guidance represents the next step in developing a regulatory framework for AI/ML-based devices as described in the January 2021 FDA’s AI/ML Software as a Medical Device Action Plan.
The FDA is requesting comments on this draft guidance by July 3, 2023, at www.regulations.gov. A webinar for interested stakeholders to discuss the draft guidance is scheduled for April 13, 2023.
Read the draft guidance. Submit comments. View webinar details.
Released our Third Biennial Report on the Risks and Benefits to Health of Non-Device Software Functions
Every two years, the FDA examines information on any risks and benefits to health associated with medical software functions that are excluded from the definition of device under amendments enacted in 2016 to Section 201(h) of the Federal Food, Drug, and Cosmetic Act. The third biennial report was released on December 8, 2022.
The analysis found more benefits than risks to patient safety and health related to these software functions. In addition, this report details best practices related to implementation, training techniques, and use, which promotes safety, education, and competency related to these software functions. Read the Report.
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We Are Hiring!
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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.
Regulatory Counsel
Seeking a regulatory counsel with expertise in regulatory affairs relating to digital health technologies. Counsel will provide legal leadership and regulatory advisement in the development, implementation, and promulgation of digital health policies and regulations. Candidates experienced with FDA regulation of digital health products are encouraged to apply.
Contact CDRH’s Digital Health Center of Excellence
Last year, the DHCoE responded to more than 700 inquiries from external stakeholders, an increase of nearly 18% since 2018. We helped 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!
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For questions about digital health regulatory policies, visit our website for helpful information and more on how to contact us.
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For general DHCoE questions, please email DigitalHealth@fda.hhs.gov.
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