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What is Digital Health

Details: The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and …

› Verified 8 days ago

› Url: https://www.fda.gov/medical-devices/digital-health-center-excellence/what-digital-health Go Now

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About the Digital Health Center of Excellence FDA

Details: A: The Digital Health Center of Excellence (DHCoE) was created to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation.

› Verified 7 days ago

› Url: https://www.fda.gov/medical-devices/digital-health-center-excellence/about-digital-health-center-excellence Go Now

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Network of Digital Health Experts FDA

Details: The Network of Digital Health Experts is comprised of a pool of vetted experts available to share knowledge and experience regarding digital health issues with FDA staff on an as-needed basis.

› Verified 9 days ago

› Url: https://www.fda.gov/medical-devices/digital-health-center-excellence/network-digital-health-experts Go Now

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Office of Minority Health and Health Equity FDA

Details: Vision. Creating a world where health equity is a reality for all. Mission. The FDA Office of Minority Health and Health Equity (OMHHE) serves to promote and protect the health of diverse

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COVID-19 Cue™ COVID-19 Test Instructions For Use For

Details: Health website at www.cuehealth.com. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high, moderate

› Verified 1 days ago

› Url: https://www.fda.gov/media/138826/download Go Now

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UV Lights and Lamps: Ultraviolet-C Radiation, Disinfection

Details: The radiological health regulations include reporting of Accidental Radiation Occurrences, notification to the FDA and customers of radiation safety defects, and designation of a U.S. agent for

› Verified 9 days ago

› Url: https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/uv-lights-and-lamps-ultraviolet-c-radiation-disinfection-and-coronavirus Go Now

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Do Cell Phones Pose a Health Hazard

Details: Public health data: The FDA also monitors and analyzes public health data on cancer rates in the U.S. population. The data clearly demonstrate no widespread rise in brain and other nervous system

› Verified 3 days ago

› Url: https://www.fda.gov/radiation-emitting-products/cell-phones/do-cell-phones-pose-health-hazard Go Now

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GMOS and Your Health

Details: Your Health Are GMO foods on the market safe to eat? Yes. GMO foods are carefully studied before they are sold to the public to ensure they are as safe as 2 the foods we currently eat. These studies 3

› Verified 1 days ago

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Health & Wellness Center International One, L.L.C. dba

Details: On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID …

› Verified 8 days ago

› Url: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/health-wellness-center-international-one-llc-dba-hotze-vitamins-607276-12022020 Go Now

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Coronavirus Disease 2019 (COVID-19) FDA

Details: The World Health Organization announced an official name for the disease that is causing the current outbreak of coronavirus disease, COVID …

› Verified 7 days ago

› Url: https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19 Go Now

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Jobs in the Digital Health Center of Excellence FDA

Details: Seeking Software Engineers, Health Scientists, Clinicians. The FDA seeks software engineers, artificial intelligence and machine learning engineers, security …

› Verified 6 days ago

› Url: https://www.fda.gov/medical-devices/digital-health-center-excellence/jobs-digital-health-center-excellence Go Now

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Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for

Details: Revised: 10 May 2021 6 • Record the date and time of dilution on the Pfizer-BioNTech COVID-19 Vaccine vial label. • Store between 2°C to 25°C (35°F to

› Verified 1 days ago

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The Critical Role of Health Care Professionals During the

Details: Speech by Commissioner Stephen M. Hahn “The Critical Role of Health Care Professionals During the COVID-19 Pandemic” August 10, 2020 Washington, DC

› Verified 8 days ago

› Url: https://www.fda.gov/news-events/speeches-fda-officials/critical-role-health-care-professionals-during-covid-19-pandemic-08102020 Go Now

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Casirivimab and Imdevimab EUA Fact Sheet for Healthcare

Details: Page 1 of 27 . FACT SHEET FOR HEALTH CARE PROVIDERS. EMERGENCY USE AUTHORIZATION (EUA) OF CASIRIVIMAB AND IMDEVIMAB . AUTHORIZED USE . The U.S. Food and Drug Administration (FDA) has issued an

› Verified 1 days ago

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Cue COVID-19 Test for Home and Over The Counter (OTC) …

Details: 3 . Test results will be reported to relevant public health authorities in accordance with local, state, and federal requirements, using appropriate LOINC and SNOMED codes, as defined by the

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Policy for COVID-19 Tests During the Public Health

Details: This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31

› Verified 9 days ago

› Url: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised Go Now

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Risks and Complications of Breast Implants FDA

Details: A silent rupture doesn't change the way an implant looks or feels, and your surgeon or health care provider may not be able to detect a silent rupture by …

› Verified 1 days ago

› Url: https://www.fda.gov/medical-devices/breast-implants/risks-and-complications-breast-implants Go Now

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FDA Launches the Digital Health Center of Excellence FDA

Details: 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

› Verified 7 days ago

› Url: https://www.fda.gov/news-events/press-announcements/fda-launches-digital-health-center-excellence Go Now

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Pulse Oximeter Accuracy and Limitations: FDA Safety

Details: Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

› Verified 2 days ago

› Url: https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication Go Now

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Fraudulent Coronavirus Disease 2019 (COVID-19) Products FDA

Details: The U.S. Food and Drug Administration is issuing warning letters to firms for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or …

› Verified 2 days ago

› Url: https://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-2019-covid-19-products Go Now

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COVID-19: An Update on the Federal Response

Details: As a public health agency and the nation’s primary resource for STLT health departments on managing disease outbreaks, CDC provides guidance and support for the development and implementation of

› Verified 7 days ago

› Url: https://www.fda.gov/news-events/congressional-testimony/covid-19-update-federal-response-09232020 Go Now

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Coronavirus (COVID-19) Update: FDA Issues Authorization

Details: 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

› Verified 7 days ago

› Url: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-authorization-first-molecular-non-prescription-home-test Go Now

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Virtual Public Meeting

Details: As stated in the Office of the National Coordinator for Health Information Technology's webpage on Patient-Generated Health Data, PGHD includes health-related data that is created, recorded, or

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Fact Sheet For Health Care Providers Emergency Use

Details: Health care providers should review the Antiviral Resistance information in Section 15 of this Fact Sheet for details regarding specific variants and resistance, and refer to the CDC website (

› Verified 1 days ago

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FDA Updates Health and Personal Hygiene Handbook for Food

Details: The U.S. Food and Drug Administration (FDA) has released an updated version of the Employee Health and Personal Hygiene Handbook for retail food managers and food employees.

› Verified 4 days ago

› Url: https://www.fda.gov/food/cfsan-constituent-updates/fda-updates-health-and-personal-hygiene-handbook-food-employees Go Now

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FDA Guidance on Conduct of Clinical Trials of Medical

Details: FDA Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Guidance for Industry, Investigators, …

› Verified 6 days ago

› Url: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-guidance-conduct-clinical-trials-medical-products-during-covid-19-public-health-emergency Go Now

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Webinars and Presentations FDA

Details: Health Equity and COVID-19: What Minority Communities Need To Know (2/25/2021) Dr. Marks and RADM Araojo will discuss the latest COVID-19 …

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› Url: https://www.fda.gov/consumers/minority-health-and-health-equity/webinars-and-presentations Go Now

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CDRH Mailing Addresses FDA

Details: Center for Devices and Radiological Health Office of the Center Director 10903 New Hampshire Avenue WO66-5431 Silver Spring, MD 20993-0002. Office of Management. U.S. Food & Drug Administration

› Verified 5 days ago

› Url: https://www.fda.gov/about-fda/cdrh-offices/cdrh-mailing-addresses Go Now

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State Retail and Food Service Codes and Regulations by

Details: Department of Health and Human Services Food Protection and Facilities, Division of Public Health Rules Governing the Sanitation of Food Service Establishments (available in PDF ) North Dakota

› Verified 6 days ago

› Url: https://www.fda.gov/food/fda-food-code/state-retail-and-food-service-codes-and-regulations-state Go Now

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2020 at FDA: A Year of Unparalleled Contributions to

Details: By: Stephen M. Hahn, M.D., Commissioner of Food and Drugs. It has been a year like no other in recent memory for public health. At the U.S. Food and Drug Administration, much of our focus has been

› Verified 7 days ago

› Url: https://www.fda.gov/news-events/fda-voices/2020-fda-year-unparalleled-contributions-public-health Go Now

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Health Scams! Don't take the risk. FDA

Details: The Food and Drug Administration (FDA) defines health fraud as the deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat

› Verified 1 days ago

› Url: https://www.fda.gov/consumers/free-publications-women/health-scams-dont-take-risk Go Now

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Women's Health Topics FDA

Details: Take Time to Care About Your Health. Women often spend so much time helping others that they don't take time for themselves. It's OK to take time to focus on good health. Watch a video or read a

› Verified 6 days ago

› Url: https://www.fda.gov/consumers/women/womens-health-topics Go Now

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Pediatric and Maternal Health

Details: The Maternal Health Team (MHT) is located within the Division of Pediatric and Maternal Health (DPMH) which is a consultative division in the Office of New Drugs (OND).

› Verified 6 days ago

› Url: https://www.fda.gov/drugs/development-resources/pediatric-and-maternal-health-about-us Go Now

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Ask a Question About Digital Health Regulatory Policies FDA

Details: Send your digital health question about medical device regulation, upcoming premarket submission, or interpreting FDA guidance directly to the relevant team.

› Verified 2 days ago

› Url: https://www.fda.gov/medical-devices/digital-health-center-excellence/ask-question-about-digital-health-regulatory-policies Go Now

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OWH Research and Development Program FDA

Details: The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update. Journal of Women's Health Vol 25. Elahi M, Eshera N, Bambata N, Barr H, Lyn-Cook B

› Verified 6 days ago

› Url: https://www.fda.gov/science-research/womens-health-research/owh-research-and-development-program Go Now

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Temporary Policy During the COVID-19 Public Health

Details: This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31

› Verified 9 days ago

› Url: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/temporary-policy-during-covid-19-public-health-emergency-regarding-qualified-exemption-standards Go Now

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Virtual Public Workshop

Details: FDA Office of Minority Health and Health Equity (OMHHE) and University of Maryland Center of Excellence in Regulatory Science and Innovation (UMD …

› Verified 9 days ago

› Url: https://www.fda.gov/consumers/minority-health-and-health-equity/virtual-public-workshop-collaborating-advance-health-equity-diabetes-and-chronic-kidney-disease Go Now

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2020 Warning Letters

Details: *The FDA defines health fraud as the deceptive promotion, advertising, distribution, or sale of a product represented as being effective to prevent, diagnose, treat, cure or lessen an illness or

› Verified 2 days ago

› Url: https://www.fda.gov/consumers/health-fraud-scams/2020-warning-letters-health-fraud Go Now

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College Women's Health FDA

Details: FDA has tips that every college woman can use. Whether you are a campus leader, college health professional, or parent, use the resources on this webpage to connect young women to health and

› Verified 4 days ago

› Url: https://www.fda.gov/consumers/take-time-care-program/college-womens-health Go Now

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Indoor Tanning: The Risks of Ultraviolet Rays FDA

Details: FDA, NCI, the American Academy of Dermatology, and other health organizations advise limiting exposure to natural UV radiation from the sun and avoiding artificial UV sources such as tanning beds

› Verified 4 days ago

› Url: https://www.fda.gov/consumers/consumer-updates/indoor-tanning-risks-ultraviolet-rays Go Now

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Tobacco Public Health Resources FDA

Details: Tobacco Regulation Issues That Impact Public Health FDA unveils new steps to protect youth by preventing access to flavored tobacco products, announces plans to ban menthol in cigarettes and cigars

› Verified 7 days ago

› Url: https://www.fda.gov/tobacco-products/health-information/tobacco-public-health-resources Go Now

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Tobacco Use in the LGBT Community: A Public Health Issue FDA

Details: Health Promotion Practice. 2004; 5(3 Suppl): 129S-134S. 5. American Lung Association. The LGBT Community: A Priority Population for Tobacco Control [PDF–367 …

› Verified 2 days ago

› Url: https://www.fda.gov/tobacco-products/health-information/tobacco-use-lgbt-community-public-health-issue Go Now

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