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June 27, 2022
Digital health is driving a revolution in health care, and the U.S. Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is helping set the stage for these advances. As an important step in promoting the advancement of digital health technology, CDRH established the Digital Health Center of Excellence (DHCoE). This update highlights DHCoE activities that promote awareness and consistent application of digital health regulatory policies to foster equity in health care; pioneer the development and enhancement of digital health regulatory paradigms; and cultivate digital health-focused collaborations.
Discover how CDRH’s Digital Health Center of Excellence is helping set the stage for the advancement of digital health technologies to help protect and promote public health.
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Digital Health Center of Excellence Activities
Updates to the "Digital Health Policies and Public Health Solutions for COVID-19" Webpage
On April 28, 2022, CDRH’s DHCoE updated the Digital Health Policies and Public Health Solutions for COVID-19 page to include the FDA’s current policies that may support public health innovation in COVID-19-related digital health technologies and the response to COVID-19. This update makes it easier for digital health stakeholders to find COVID-19-specific policy examples in one place.
Promote equity in health care, awareness, and consistent application of digital health policies
Upcoming Patient Engagement Advisory Committee Meeting on Augmented Reality and Virtual Reality (AR/VR)
On July 12-13, 2022, the Patient Engagement Advisory Committee (the Committee) will meet to discuss and make recommendations on Augmented Reality (AR) and Virtual Reality (VR) Medical Devices. The Committee will discuss and make recommendations on factors to consider when evaluating AR/VR devices. The Committee will also discuss specific challenges related to vulnerable populations who may use this technology. View meeting details.
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Leading the development and enhancement of new regulatory frameworks tailored to digital health technologies
Webinar on Draft Guidance for Digital Health Technologies
On February 10, 2022, the FDA held a webinar to provide an overview and answer questions about the new draft guidance on Digital Health Technologies (DHTs) for Remote Data Acquisition.
When final, this guidance will provide clarity to encourage the exploration of these technological advances in clinical investigations including:
- Steps to help ensure a DHT is fit-for-purpose for remote data collection use in a clinical investigation;
- Guidance on when sponsors should engage with the FDA to discuss use of DHTs in a specific clinical investigation;
- Guidance on when a qualified DHT may be relied upon in multiple clinical investigations to support premarket submissions for drugs or biological products; and
- Proposed recommendations on the use of electronic records in clinical investigations of medical products.
Read the Draft Guidance. Watch the Webinar.
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Issued Draft Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions
On April 8, 2022, the FDA issued a draft guidance intended to further emphasize the importance of ensuring that devices are designed securely, enabling emerging cybersecurity risks to be mitigated throughout the Total Product Life Cycle, and to outline the FDA’s recommendations more clearly for premarket submission content to address cybersecurity concerns.
The guidance notes four general principles that are important to the improvement of device cybersecurity. When followed, these are expected to have a positive impact on patient safety:
- Cybersecurity is part of device safety and the quality system regulations
- Designing for security
- Transparency
- Submission documentation
Read and comment on the Draft Guidance. Comments will be accepted on the draft guidance until July 7, 2022. Watch the Webinar.
Draft Guidance: Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program
On May 5, 2022, the FDA issued a draft guidance that, when finalized, is intended to describe the FDA’s policy on its participation in the Voluntary Improvement Program. The Voluntary Improvement Program is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturers’ practices using third-party appraisals to enhance the quality of devices. This program is intended to guide improvement to enhance the quality of devices.
Read and comment on the Draft Guidance. Comments will be accepted on the draft guidance until July 7, 2022.
Fostering digital health-focused partnerships, coordination, and collaboration
Digital Health Measurement Collaborative Community (DATAcc) Launched Resources to Drive Digital Health Measurement
On May 25, 2022, the Digital Health Measurement Collaborative Community (DataCC), hosted by the Digital Medicine Society, announced a new set of open-access resources to guide inclusivity in the development and deployment of digital health measurement products. The resources provide product developers and clinical users with tools to help realize the promise of digital health measurement to improve lives for everyone. The FDA participates in the DataCC.
This launch includes two toolkits for the inclusive development and deployment of digital health measurement products. The development toolkit provides supporting tools and research to take digital health measurement products from initial concept to the regulatory approval process. The deployment toolkit helps guide users toward an inclusive approach when deploying digital health measurement products in healthcare and research. View the Inclusive Development Toolkit and the Inclusive Deployment Toolkit.
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International Medical Device Regulators Forum (IMDRF) Publishes Document for Terminology of Machine Learning-enabled Medical Devices
On May 9, 2022, the IMDRF Artificial Intelligence Medical Devices Working Group published “Machine Learning-enabled Medical Devices: Key Terms and Definitions.” This publication is an important step towards harmonizing terms and definitions related to machine learning to promote consistency and support global harmonization efforts for these devices across jurisdictions. International harmonization is an important part of the Digital Health Center of Excellence’s work to ensure that patients in the U.S. have access to safe and effective digital health technologies. Read the key terms and definitions.
IMDRF Requests Comment on Cybersecurity of Legacy Medical Devices
On May 4, 2022, the IMDRF Medical Device Cybersecurity Guide Working Group proposed “Principles and Practices for the Cybersecurity of Legacy Medical Devices.” When final, this document will provide stakeholders with clear ways of identifying potential legacy devices and practical, feasible approaches for implementing cybersecurity of legacy medical devices. Read the principles and practices and provide comments.
We Are Hiring!
We are continuing to build a dynamic team who is at the forefront to advance medical science, create new opportunities, and create a regulatory environment that brings safe and effective digital health technology 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
Fellowship Opportunities!
The FDA fellowships provide opportunities for health and software development professionals to participate in the FDA’s regulatory processes and decision-making. Fellowship opportunities in the Digital Health Center of Excellence are ideal for individuals interested in learning about the regulatory process and sharing their knowledge and experience with digital health technologies. Interested applicants should email a CV and cover letter to DigitalHealth@fda.hhs.gov.
Data Scientist
Seeking experts who will be responsible for planning, leading, and coordinating data science related activities for the Digital Health Center of Excellence. Read the job description.
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. Also seeking experts in modern software delivery; and seeking experts in policy applicable to the FDA and digital health technologies. 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.
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Contact CDRH's Digital Health Center of Excellence
We help our stakeholders navigate the FDA's current policies on digital health products and provide informal feedback on the possible regulatory status of products in development. Please contact 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 Digital Health Center of Excellence questions, please email DigitalHealth@fda.hhs.gov.
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