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Medical Device Advice, Inc.

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LINKS TO FDA NEWS, ALERTS, RESOURCES & VIDEOS

Increased demand for Medical Devices during..

Increased demand for Medical Devices during..

Increased demand for Medical Devices during..

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FAQs on Testing for SARS-CoV-2

Increased demand for Medical Devices during..

Increased demand for Medical Devices during..

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COVID-19 Frequently Asked Questions

Increased demand for Medical Devices during..

FAQs on EUAs for Medical Devices during..

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FAQs on EUAs for Medical Devices during..

FAQs on EUAs for Medical Devices during..

FAQs on EUAs for Medical Devices during..

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COVID-19 EUA information from FDA

FAQs on EUAs for Medical Devices during..

COVID-19 EUA information from FDA

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COVID-19 and Medical Devices

FAQs on EUAs for Medical Devices during..

COVID-19 EUA information from FDA

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FDA COVID-19 Update: April 9, 2021

COVID-19 Emergency Use Authorization...

COVID-19 Emergency Use Authorization...

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COVID-19 Emergency Use Authorization...

COVID-19 Emergency Use Authorization...

COVID-19 Emergency Use Authorization...

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FDA COVID-19 Update: April 6, 2021

COVID-19 Emergency Use Authorization...

FDA allows more flexible storage for Pfizer...

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FDA allows more flexible storage for Pfizer...

FDA allows more flexible storage for Pfizer...

FDA allows more flexible storage for Pfizer...

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Know your treatment options for Covid-19

FDA allows more flexible storage for Pfizer...

FDA makes revisions to Moderna vaccine...

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FDA makes revisions to Moderna vaccine...

FDA allows more flexible storage for Pfizer...

FDA makes revisions to Moderna vaccine...

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FDA approves first continuous glucose monitoring system for..

FDA clears first duodenoscope with disposable distal cap

FDA clears first duodenoscope with disposable distal cap

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FDA clears first duodenoscope with disposable distal cap

FDA clears first duodenoscope with disposable distal cap

FDA clears first duodenoscope with disposable distal cap

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FDA clears mammography device with option for ....

FDA clears first duodenoscope with disposable distal cap

FDA clears first neonatal magnetic resonance imaging device

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FDA clears first neonatal magnetic resonance imaging device

FDA clears expanded use of cooling cap to reduce hair loss during ...............

FDA clears first neonatal magnetic resonance imaging device

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FDA clears expanded use of cooling cap to reduce hair loss during ...............

FDA clears expanded use of cooling cap to reduce hair loss during ...............

FDA clears expanded use of cooling cap to reduce hair loss during ...............

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FDA allows marketing of test to aid in the detection of ...........

FDA clears expanded use of cooling cap to reduce hair loss during ...............

FDA clears expanded use of cooling cap to reduce hair loss during ...............

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FDA expands use of Sapien 3 artificial heart valve for high-risk patients

FDA warns Americans about risk of inaccurate results from certain lead tests

FDA warns Americans about risk of inaccurate results from certain lead tests

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FDA warns Americans about risk of inaccurate results from certain lead tests

FDA warns Americans about risk of inaccurate results from certain lead tests

FDA warns Americans about risk of inaccurate results from certain lead tests

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FDA authorizes use of new device to treat esophageal birth defect in babies

FDA warns Americans about risk of inaccurate results from certain lead tests

FDA allows marketing of first direct-to-consumer tests that provide genetic risk information .......

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FDA allows marketing of first direct-to-consumer tests that provide genetic risk information .......

FDA allows marketing of first direct-to-consumer tests that provide genetic risk information .......

FDA allows marketing of first direct-to-consumer tests that provide genetic risk information .......

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Smiths Medical Recalls Sterile Saline and Sterile Water for Inhalation Due to Potential Exposure

FDA allows marketing of first direct-to-consumer tests that provide genetic risk information .......

Smiths Medical Recalls Sterile Saline and Sterile Water for Inhalation Due to Potential Exposure

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FDA Warns Against Use of Teething Necklaces, Bracelets, and Other Jewelry Marketed .....

FDA allows marketing of first direct-to-consumer tests that provide genetic risk information .......

Smiths Medical Recalls Sterile Saline and Sterile Water for Inhalation Due to Potential Exposure

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FDA issues warning letter to doctor for illegally marketing unapproved device with claims ........

FDA issues warning letter to doctor for illegally marketing unapproved device with claims ........

FDA issues warning letter to doctor for illegally marketing unapproved device with claims ........

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FDA Evaluation of Automatic Class III Designation (De Novo) Summaries

FDA issues warning letter to doctor for illegally marketing unapproved device with claims ........

FDA issues warning letter to doctor for illegally marketing unapproved device with claims ........

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Edwards Lifesciences Recalls Swan-Ganz Thermodilution Catheter Due to .....

FDA issues warning letter to doctor for illegally marketing unapproved device with claims ........

Edwards Lifesciences Recalls Swan-Ganz Thermodilution Catheter Due to .....

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FDA Medical Device Bans To Protect Public Health

FDA Medical Device Bans To Protect Public Health

Edwards Lifesciences Recalls Swan-Ganz Thermodilution Catheter Due to .....

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FDA Medical Device Recalls Database

FDA Medical Device Bans To Protect Public Health

FDA's Recently-Approved Medical Devices

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FDA's Recently-Approved Medical Devices

FDA Medical Device Bans To Protect Public Health

FDA's Recently-Approved Medical Devices

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Inspiring Medical Device Innovation to Combat the Opioid ......

Inspiring Medical Device Innovation to Combat the Opioid ......

Inspiring Medical Device Innovation to Combat the Opioid ......

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Brain Implant for Some Blind People Shows Benefits of .......

Inspiring Medical Device Innovation to Combat the Opioid ......

Inspiring Medical Device Innovation to Combat the Opioid ......

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Using Symbols to Convey Information in Medical Device Labeling

Inspiring Medical Device Innovation to Combat the Opioid ......

Using Symbols to Convey Information in Medical Device Labeling

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Consumers (Medical Devices)

Industry (Medical Devices)

Using Symbols to Convey Information in Medical Device Labeling

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Health Care Providers (Medical Devices)

Industry (Medical Devices)

Industry (Medical Devices)

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Industry (Medical Devices)

Industry (Medical Devices)

Industry (Medical Devices)

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FDA AND CDC RECOMMENDS LIFTING THE PAUSE ON JANSSEN

Joint virtual press conference with the U.S. Centers for Disease Control and Prevention and the U.S. Food and Drug Administration to discuss the lifting of the pause on Johnson & Johnson (Janssen) COVID-19 Vaccine.

KNOW YOUR TREATMENT OPTIONS FOR COVID-19

Patients today have more treatment options in the battle against coronavirus disease. The U.S. Food and Drug Administration has approved three drug treatment for COVID-19 and has authorized others for emergency use during this public health emergency. In addition, many more therapies are being tested in clinical trials to evaluate whether they are safe and effective in combating COVID-19.

AN INTRODUCTION TO FDA’s REGULATION OF MEDICAL DEVICES

In this video, Elias Mallis explains FDA’s role in regulating medical devices, review the actual definition and some basics about device classification. He describes the steps to get a new product to market and the different types of premarital regulatory submissions that might be sent. Lastly, identifying three actions that should be taken after watching this video.

Patients Matter: FDA’s Office of Orphan Products Development

This video segment describes how FDA is administering funding to support innovative clinical trial methods and research for the millions of people with rare diseases through their Orphan Products and Natural History Grants Programs. These grants are open to foreign or domestic, public or private, for-profit or nonprofit entities, including patient advocacy groups, academicians, and industry.

How FDA-Approved Devices Help Patients with Rare Diseases

The U.S. Food and Drug Administration regulates medical devices, as Jeffrey Shuren, M.D., J.D., Director of FDA's Center for Devices and Radiological Health explains. To help ensure patients with rare diseases have access to needed medical devices, the FDA established the Humanitarian Use Device Program. The program began in 1990 and, since then, FDA has approved 72 devices for rare diseases. Here, agency experts describe three of them.

3 Tips About X-ray Imaging for Children

FDA's Center for Devices and Radiological Health (CDRH) regulates medical imaging devices, including X-ray machines that emit ionizing radiation. While  X-ray imaging has led to significant improvements in the diagnosis and treatment of medical conditions in children, it is important that their exposure to radiation be minimized.

FDA Medical Device User Fee Amendments of 2017 (MDUFA IV)

This video highlights the main program areas of the FDA Medical Device User Fee Amendments of 2017 (MDUFA IV), designed to advance how FDA fosters innovation and regulates medical devices for patients.

5 Ways to Safely Use Nail Drying and Curing Lamps

If you’ve used gel nail polish, or have acrylic or gel nails, you’ve probably used ultraviolet (UV) nail curing lamps. These lamps are used to dry or “cure” acrylic or gel nails and gel nail polish, and they feature lamps or LEDs that emit UV radiation. Learn five ways to help reduce your UV exposure from these nail curing lamps—and how to use these products safely.


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