Fda.gov

What is Digital Health

Digital health technologies use computing platforms, connectivity, software, and sensors for health care and related uses. These technologies span a wide range of uses, from applications in

Actived: 8 days ago

URL: https://www.fda.gov/medical-devices/digital-health-center-excellence/what-digital-health

Digital Health Reports FDA

(1 days ago) Health IT is the framework that enables the management of health information across multiple electronic systems and devices, such as wireless medical …

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Health Information on the Web FDA

(Just Now) Tweeting, Posting, and Downloading Health Information. The use of social media for health communication is on the rise – both as a resource for consumers and as an outreach tool for health

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Topics in Public Health FDA

(8 days ago) 15 rows · The Topics in Public Health (TPH) Series is a complimentary educational …

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Health Fraud Scams FDA

(8 days ago) Health fraud scams refer to products that claim to prevent, treat, or cure diseases or other health conditions, but are not proven safe and effective for those uses. Health

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Women's Health Topics FDA

(6 days ago) Contact the FDA Office of Women's Health. Contact Point. Food and Drug Administration. Office of Women's Health. 10903 New Hampshire Ave WO32-2333. Silver Spring, MD 20993. [email protected]gov

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About the Digital Health Center of Excellence FDA

(7 days ago) 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. The DHCoE is part

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Digital Health Policies and Public Health Solutions for

(7 days ago) The FDA recognizes that digital health technologies can provide powerful tools for public health officials and the public in the management of the COVID-19 response by helping public health

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Health Fraud & COVID-19: What You Need to Know FDA

(8 days ago) Health Fraud & COVID-19: What You Need to Know. RADM Richardae Araojo is joined by CAPT Jason Humbert and Minerva Rogers from the Health Fraud Branch in the Office of Regulatory Affairs at FDA to

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Health Hazard Evaluations (HHEs) and Health Risk

(1 days ago) Health Hazard Evaluations (HHEs) and Health Risk Assessments (HRAs) are the processes that FDA follows to determine the risks of certain device problems and the actions firms should take to

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Minority Health and Health Equity Resources FDA

(7 days ago) FDA Office of Minority Health and Health Equity (OMHHE) offers many easy-to-use and culturally-appropriate resources on minority health, health disparities, and …

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More Women's Health Topics FDA

(6 days ago) FDA information on a variety of women's health topics. Healthy Eating/ Nutrition. The FDA has information to help you make good food choices.

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A Decade of FDA Advancing Health Equity FDA

(7 days ago) A Decade of FDA Advancing Health Equity. By: RADM Richardae Araojo, Pharm.D., M.S., Associate Commissioner for Minority Health. The U.S. Food and Drug Administration is working around the clock

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Coronavirus (COVID-19) Update: FDA Authorizes Drug for

(8 days ago) 1 hour ago · The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, …

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College Women's Health FDA

(4 days ago) General Health - Learn how to deal with common health concerns. Sun Safety - Avoid the dangers of tanning. Reproductive Health - Learn the facts about HPV, HIV, and birth control.

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2020 Warning Letters

(2 days ago) *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

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FDA’s Budget: Maternal and Infant Health and Nutrition FDA

(5 days ago) 8 hours ago · FDA’s FY 2022 budget includes important funding to core food safety programs to address unmet public health funding needs, as well as emerging …

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CDRH Health of Women Program FDA

(4 days ago) The CDRH Health of Women Program will explore unique issues related to the performance of medical devices in women, improve analysis and communication of sex- and gender-specific data to better

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Tobacco Use and Men’s Health FDA

(3 days ago) Smokeless tobacco use can lead to health problems, including cavities, gum disease and tooth loss, 12 and more serious diseases like cancers of the mouth, esophagus, and pancreas. 13 Each year

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2020 at FDA: A Year of Unparalleled Contributions to

(7 days ago) 2020 at FDA: A Year of Unparalleled Contributions to Public Health. It has been a year like no other in recent memory for public health. At the U.S. Food and Drug Administration, much of …

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Pacific Center of Health/Pacific Center of Health

(9 days ago) 1 day ago · On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID …

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Warning Letters

(7 days ago) *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

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Fraudulent Coronavirus Disease 2019 (COVID-19) Products FDA

(2 days ago) 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 …

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FDA authorizes revisions to fact sheets to address SARS

(4 days ago) The agency is committed to ensuring health care providers and health officials have the best information so patients may receive the most appropriate treatment …

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Do Cell Phones Pose a Health Hazard

(3 days ago) 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

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FDA’s Budget: Advancing the Goal of Ending the Opioid

(Just Now) FDA’s FY 2022 budget request would address current public health needs and allow the agency to design programs intended to tackle complex challenges facing the …

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Division of Pediatric and Maternal Health FDA

(6 days ago) About Us. The Division of Pediatric and Maternal Health (DPMH) is located in the Office of New Drugs. DPMH oversees quality initiatives which promote and necessitate the study of drug and

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Smoking: A Women’s Health Issue FDA

(3 days ago) The Health Consequences of Smoking: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Center for Disease Control and Prevention, National Center for

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FDA and Health Canada Regional ICH Consultation

(5 days ago) FDA and Health Canada will be co-hosting a regional public meeting to provide information and receive comments on current International Council for Harmonisation of Technical Requirements for

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FDA Addresses Health Disparities Through Communication

(4 days ago) The disparities in health span everything from cancer and diabetes to heart disease, sickle cell disease, and HIV/AIDS. The FDA’s work on these issues is a priority—and is intrinsic to the

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Enforcement Policy Regarding Use of National Health

(Just Now) This guidance describes the Agency's policy regarding the prohibition against providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on …

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Tobacco Public Health Resources FDA

(7 days ago) Tobacco Public Health Resources. FDA's Center for Tobacco Products (CTP) regulates the manufacturing, marketing, and distribution of tobacco products. Tobacco use …

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Webinars and Presentations FDA

(Just Now) 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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Health Equity Forum Podcast FDA

(1 days ago) FDA's Health Equity Forum podcast series is a platform for experts to come together and have meaningful conversations around health topics that impact the lives and well-being of …

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Hoffmann-La Roche, Ltd. C/O Genentech, Inc. Attention

(1 days ago) Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of

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The FDA’s Critical Focus on Women’s Health FDA

(6 days ago) The Office of Women’s Health (the Office) was established in 1994 and throughout its history has protected and advanced the health of women through science, policy, education, and outreach, and

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Ask a Question About Digital Health Regulatory Policies FDA

(2 days ago) Send your digital health question about medical device regulation, upcoming premarket submission, or interpreting FDA guidance directly to the relevant team.

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Street Device: Lucira COVID-19 All-In-One Test Kit

(1 days ago) Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of

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Anna Health, LLC

(Just Now) The claims on your website establish that the products Fucoidan, Prostate Health, Children Liquid Vitamins, and Immune Health are drugs under section 201 (g)(1)(B) of …

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(Just Now) Health Hazard Evaluation or Health Risk Assessment . Center for Devices and Radiological Health Date: RES #: III. Health Risks . TO BE COMPLETED BY MEDICAL OFFICER OR COMMITTEE

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Virtual Public Workshop

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

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Class 2 Device Recall OPTICHAMBER DIAMOND SPACER WITH

(4 days ago) On 03/16/2021, Cardinal Health issued an Urgent Medical Device Removal notice to customer via letter notifying them a recall is being initiated as a precautionary measure as a result of exposure to temperatures outside of the products labeling requirements. Actions Required 1. INSPECT your inventory for the affected product. 2.

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