Banned Medical Testing Devices

Medical Device Bans | FDA - U.S. Food and Drug …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-bans

The FDA has the authority to ban a medical device if it finds that the device presents a ...

Fact Check-FDA did not recall all COVID-19 PCR tests | Reuters

https://www.reuters.com/article/factcheck-fda-pcr-test-idUSL1N2P51XC

A current list of medical products recalled (including dates) by the FDA is viewable here . According to the 2021 medical device recall list, the Innova Medical …

General Controls for Medical Devices | FDA

https://www.fda.gov/medical-devices/regulatory-controls/general-controls-medical-devices

Stop Innova Medical Group SARS-CoV-2 Antigen Rapid …

https://www.fda.gov/medical-devices/safety-communications/stop-using-innova-medical-group-sars-cov-2-antigen-rapid-qualitative-test-fda-safety-communication

Date Issued: June 10, 2021 The U.S. Food and Drug Administration (FDA) is warning the public to stop using the Innova Medical Group SARS-CoV-2 Antigen Rapid …

Safety of Metals and Other Materials Used in Medical …

https://www.fda.gov/medical-devices/products-and-medical-procedures/safety-metals-and-other-materials-used-medical-devices

The FDA believes this is an important first step to ensure patients and physicians have access to more comprehensive information on different materials …

Direct-to-Consumer Tests | FDA

https://www.fda.gov/medical-devices/in-vitro-diagnostics/direct-consumer-tests

In general, direct-to-consumer tests for non-medical, general wellness, or low risk medical purposes are not reviewed by the FDA before they are offered. Direct-to-consumer tests …

Restricted Substances under the New Medical Devices …

https://www.intertek.com/blog/2020-06-22-mdr/

As per the new MDR, medical devices can not contain CMR and/or endocrine-disrupting substances in a concentration above 0.1% weight by …

Unapproved Chinese coronavirus tests …

https://www.nbcnews.com/health/health-news/unapproved-chinese-coronavirus-antibody-tests-being-used-least-2-states-n1185131

Because the Chinese government banned manufacturers from exporting COVID-19 test kits after April 1 if they are unapproved, Fang said, Zhejiang Orient …

Sterilization for Medical Devices | FDA

https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices

Medical devices are sterilized in a variety of ways including using moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, and other …

FDA bans electrical shock devices used on …

https://www.cnn.com/2020/03/05/health/fda-bans-electrical-shock-device/index.html

The FDA announced a ban on such devices on Wednesday. Charles Krupa/AP CNN — Electrical shock devices meant to interrupt self-injurious or aggressive …