FDA Medical Devices (@FDADeviceInfo) / X

FDA Medical Devices

8,746 posts

FDA Medical Devices

@FDADeviceInfo

Official FDA - device recalls, safety, authorizations, radiation-emitting products. Contact us [email protected] or 800-638-2041 fda.gov/privacy

Silver Spring, Maryland, USA

fda.gov/medical-device…

Joined May 2010

FDA Medical Devices
@FDADeviceInfo
Dec 29, 2022
Today, @US_FDA updated our SARS-CoV-2 Viral Mutations: Impact on #COVID-19 Tests web page to add DxTerity SARS-CoV-2 RT PCR CE Test as a test expected to have reduced performance for the SARS-CoV-2 Omicron Variant and Sub-Variants. fda.gov/medical-device…
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FDA Medical Devices
@FDADeviceInfo
Jun 15, 2020
Replying to @FDADeviceInfo
Today, the Agency permitted the marketing of EndeavorRx, the first game-based digital therapeutic device to improve attention function in children with attention deficit hyperactivity disorder (ADHD).
FDA Medical Devices
@FDADeviceInfo
Aug 11, 2022
Today, the @US_FDA is advising people to perform repeat, or serial, testing following a negative result on any at-home COVID-19 antigen test, whether or not you have symptoms. Find out more: go.usa.gov/xSMvf
FDA Medical Devices
@FDADeviceInfo
Jun 15, 2020
Replying to @FDADeviceInfo
EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. Find out more go.usa.gov/xwUXh
FDA Medical Devices
@FDADeviceInfo
Jan 4, 2021
Today, the @US_FDA is alerting patients and health care providers of the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test.
FDA Medical Devices
@FDADeviceInfo
Mar 25, 2020
All hands and supplies are on deck in the fight against #COVID19. Today @US_FDA’s CDRH sent our supply of gloves, masks, gowns, and N95 respirators from our Office of Science and Engineering Laboratories to the Clinical Center at @NIH.
FDA Medical Devices
@FDADeviceInfo
Feb 6, 2023
Did you know you can very easily report your at-home test result for #COVID19 at MakeMyTestCount.org? Today, the @US_FDA updated its step-by-step guide to include information about why this is important. Find out more: fda.gov/medical-device….?utm_source=CDRHTwitterD
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FDA Medical Devices
@FDADeviceInfo
Sep 22, 2020
Today, the @US_FDA launched the Digital Health Center of Excellence (DHCoE.) The DHCoE seeks to empower digital health stakeholders to advance healthcare by fostering responsible and high-quality digital health innovation.
FDA Medical Devices
@FDADeviceInfo
Mar 8, 2017
Do not swim while wearing contacts. There is a risk of eye infection frm bacteria in pools, hot tubs, lakes & ocean. #SpringBreak2017
FDA Medical Devices
@FDADeviceInfo
May 20, 2020
Have questions about device shortages, enforcement policies, and other #COVID19 related topics? Check out the @US_FDA’s comprehensive directory of email addresses for medical device questions during the #COVID19 pandemic. go.usa.gov/xvS85
FDA Medical Devices
@FDADeviceInfo
Oct 29, 2021
The @US_FDA issued an emergency use authorization #EUA for the 11th over-the-counter COVID-19 test➡️ the Detect Covid-19 Test, an OTC #COVID19 diagnostic molecular test. go.usa.gov/xea9s
FDA Medical Devices
@FDADeviceInfo
Apr 15, 2022
Replying to @FDADeviceInfo
On April 14, 2022, the FDA issued an emergency use authorization (EUA) for InspectIR COVID-19 Breathalyzer, a #COVID19 diagnostic test that uses breath samples to detect SARS-CoV-2. Find out more. go.usa.gov/xuThc
FDA Medical Devices
@FDADeviceInfo
Jan 5, 2021
The @US_FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. Since the start of the pandemic, we have authorized over 300 tests and collection kits. go.usa.gov/xAXNW
FDA Medical Devices
@FDADeviceInfo
Dec 15, 2022
Many at-home #COVID19 tests have expiration dates that have been extended! Check if your @US_FDA authorized at-home COVID-19 test has a new expiration date. fda.gov/medical-device…
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