Trending...
- Maryland: Urban Agriculture Advisory Committee Meeting Notice
- PUBLIC NOTICE UPDATE: Maryland Agencies to Treat Potomac River for Black Fly Control on June 30
- The Naturist World Just Shifted — NaturismRE Ignites a Global Resurgence
SILVER SPRING, Md., Sept. 22, 2020 /PRNewswire/ -- Today, the U.S. Food and Drug Administration announced it is launching the Digital Health Center of Excellence within the Center for Devices and Radiological Health (CDRH). The launch of the Digital Health Center of Excellence is an important step in furthering the agency's overarching dedication to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.
"Establishing the Digital Health Center of Excellence is part of the FDA's work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S.," said FDA Commissioner Stephen M. Hahn, M.D. "Today's announcement marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings. The Digital Health Center of Excellence will provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff."
More on Marylandian
The FDA will continue to build and formalize the coordinating structure and operation of the Digital Health Center of Excellence as part of an effort to modernize digital health policies and regulatory approaches, and provide efficient access to highly specialized expertise, knowledge, and tools to accelerate access to safe and effective digital health technology. The agency is appointing Bakul Patel as the first director. Bakul Patel has been leading regulatory and scientific efforts related to digital health devices at the FDA since 2010.
"The establishment of the Digital Health Center of Excellence is part of the planned evolution of the FDA's digital health program to amplify the digital health work that is already being done and building upon years of work at the agency," said Jeff Shuren, M.D., J.D., director of CDRH. "In the last several years, we have established partnerships internally and externally to coordinate digital health activities and to promote the consistency of regulatory policy while continuing to innovate in our regulatory approaches."
The Digital Health Center of Excellence is primarily focused on helping both internal and external stakeholders achieve their goals of getting high quality digital health technologies to patients by providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimagining digital health device oversight. Along those lines, the Digital Health Center of Excellence is creating a network of digital health experts and engaging in Collaborative Communities to share knowledge and experience concerning digital health issues and priorities with FDA staff. An integral part of the launch includes the activities that will be provided to complement advances in digital health technology – such as launching strategic initiatives that advance digital health technologies, facilitating synergies in regulatory science research in digital health, and facilitating and building strategic partnerships.
More on Marylandian
The Digital Health Center of Excellence is committed to strategically advancing science and evidence for digital health technologies within the framework of the FDA's regulatory and oversight role. While there are many aspects of the Digital Health Center of Excellence that are still under development, ultimately the goal is to empower digital health stakeholders to advance health care by fostering responsible and high-quality digital health innovation.
Additional Resources:
Media Contact: Nikki Mueller, 240-620-8173
Consumer Inquiries: Email, 888-INFO-FDA
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
SOURCE U.S. Food and Drug Administration
Related Links
http://www.fda.gov
"Establishing the Digital Health Center of Excellence is part of the FDA's work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S.," said FDA Commissioner Stephen M. Hahn, M.D. "Today's announcement marks the next stage in applying a comprehensive approach to digital health technology to realize its full potential to empower consumers to make better-informed decisions about their own health and provide new options for facilitating prevention, early diagnosis of life-threatening diseases, and management of chronic conditions outside of traditional care settings. The Digital Health Center of Excellence will provide centralized expertise and serve as a resource for digital health technologies and policy for digital health innovators, the public, and FDA staff."
More on Marylandian
- $18 Price Target Issued in New Research Report After $34 Million Revenue Forecast from Acquisition; $101.5 Million Net Revenue in 2025; NAS DAQ: IQST
- West Dentistry Welcomes New Oral Surgeon to Enhance Patient Care
- The AML Shop Launches New Financial Investigations Unit, Appoints Director to Lead the Initiative
- Raidium révolutionne le diagnostic de la Sclérose en Plaques en partenariat avec l'Hôpital Fondation Adolphe de Rothschild
- New Podcast "Spreading the Good BUZZ" Hosted by Josh and Heidi Case Launches July 7th with Explosive Global Reach and a Mission to Transform Lives
The FDA will continue to build and formalize the coordinating structure and operation of the Digital Health Center of Excellence as part of an effort to modernize digital health policies and regulatory approaches, and provide efficient access to highly specialized expertise, knowledge, and tools to accelerate access to safe and effective digital health technology. The agency is appointing Bakul Patel as the first director. Bakul Patel has been leading regulatory and scientific efforts related to digital health devices at the FDA since 2010.
"The establishment of the Digital Health Center of Excellence is part of the planned evolution of the FDA's digital health program to amplify the digital health work that is already being done and building upon years of work at the agency," said Jeff Shuren, M.D., J.D., director of CDRH. "In the last several years, we have established partnerships internally and externally to coordinate digital health activities and to promote the consistency of regulatory policy while continuing to innovate in our regulatory approaches."
The Digital Health Center of Excellence is primarily focused on helping both internal and external stakeholders achieve their goals of getting high quality digital health technologies to patients by providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimagining digital health device oversight. Along those lines, the Digital Health Center of Excellence is creating a network of digital health experts and engaging in Collaborative Communities to share knowledge and experience concerning digital health issues and priorities with FDA staff. An integral part of the launch includes the activities that will be provided to complement advances in digital health technology – such as launching strategic initiatives that advance digital health technologies, facilitating synergies in regulatory science research in digital health, and facilitating and building strategic partnerships.
More on Marylandian
- The Herbal Care, Led by Markel Bababekov, Becomes a Top Dispensary in NYC's Upper East Side
- Digital Watchdog Launches New myDW Cloud Services
- Stan Fitzgerald Appointed Acting Press Secretary for Veterans for America First VFAF Georgia State Chapter
- Drone Light Shows Emerge as the New Standard in Live Event Entertainment
- Lore Link is Here to Help Organize Your Game
The Digital Health Center of Excellence is committed to strategically advancing science and evidence for digital health technologies within the framework of the FDA's regulatory and oversight role. While there are many aspects of the Digital Health Center of Excellence that are still under development, ultimately the goal is to empower digital health stakeholders to advance health care by fostering responsible and high-quality digital health innovation.
Additional Resources:
Media Contact: Nikki Mueller, 240-620-8173
Consumer Inquiries: Email, 888-INFO-FDA
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
SOURCE U.S. Food and Drug Administration
Related Links
http://www.fda.gov
Filed Under: Business
0 Comments
Latest on Marylandian
- $17.4 Million Total Revenue for First Half of 2025 (up 31.8% YOY) for Global Wet Trades Services Provider with High Value Bitcoin Investments
- $12.8 Million Net Revenue for 2024 for Cloud-Based Crowdsourcing Recruitment and SaaS-Enabled HR Solutions Provider: Baiya International Group Inc
- YYNOT Brings High-Energy RUSH Tribute to the Weinberg Center this September
- Hire Virtue Announces Executive Sponsorship Opportunity for Houston Hiring Blitz & Job Fair on August 6, 2025
- Inked & Maxim Model Teisha Mechetti Turns Heads—And Builds Community Impact
- Plan to Launch Silo Technologies' Cybersecurity Pilot Program for Ultimate Nationwide Deployment via Exclusive Partnership: Stock Symbol: BULT
- Robert Michael & Co. Real Estate Team Celebrates Industry Recognition and Showcases Premier Central Florida Listings
- AI-Based Neurotoxin Countermeasure Initiative Launched to Address Emerging National Security Needs: Renovaro, Inc. (N A S D A Q: RENB)
- The Naturist World Just Shifted — NaturismRE Ignites a Global Resurgence
- PUBLIC NOTICE UPDATE: Maryland Agencies to Treat Potomac River for Black Fly Control on June 30
- Maryland: Urban Agriculture Advisory Committee Meeting Notice
- $796,000 in Q2 Revenue Marks Highest Earnings to Date on 3 Trailing Quarters of Profitability in Multi-Billion Homebuilding Sector: Stock Symbol: IVDN
- Cybersecurity is THE Hot Market Sector; Revenues, Earnings & Profit matter; Only 33 Million Shares + a Huge Short Position Equal an Undervalued Stock
- Despite Global Calls for a Ban, US Child Psychiatry Pushes Electroshock for Kids
- Franco Polished Plaster Celebrates 35 Years of Bringing Walls to Life in the UK
- Spartan & Guardians Partner with Guitar Legend Buckethead to Support Global Child Rescue Efforts
- Preliminary.online Introduces Short-Term Job-Readiness Courses with Employer-Verified Certifications
- Psychologist-Turned-Hermeticist Releases Modern Guide to the Seven Hermetic Principles
- Winners Announced for Asia Pacific Business Awards 2024-2025
- Hamvay-Lang and Lampone.hu Join Forces with AIMarketingugynokseg.hu to Elevate Hungarian Lifestyle Brands on the Global Stage