CDRH Prepares to Take On 2022 While Managing Unprecedented Workload
The center is also hoping to move back into more normal review timelines next year.
Tag Archives: emergency use authorization
FDA Revokes EUAs for Certain Non-NIOSH-Certified Respirators
The agency action includes all non-NIOSH-approved disposable respirators, including imported KN95s.
Remote Audits and Other New Ways of Working in a Post-COVID MedTech World
Audits for medical device companies and other organizations in the medtech space used to be primarily in person. However, the pandemic magnified flaws in the global regulatory process. A shift to remote audits may be the key to interorganizational and international regulatory harmonization moving forward.
FDA Revokes EUA for Battelle Decontamination System
The CCDS system was used to decontaminate compatible N95 respirators for multiple re-use.
CDRH Reflects One Year into Pandemic, Sets Some Expectations for Road Ahead
The center is working to address the delays in meeting review timelines for product submissions.
MedTech Leads Industries in Recalls, Numbers Expected to Rise in 2021
Software continues to be a key factor in recalls, and this year the end of some EUAs may also contribute to an increase.
First At-Home, Molecular OTC Diagnostic Test for COVID-19 Wins FDA Authorization
The test generates results within 20 minutes and can be used by adults and children over the age of two years old.
In 2020, FDA Authorized 132 Novel Medical Devices
The record-high number of authorizations last year was a significant jump over 2019.
COVID-19 Introduces New Risks, Hazards in Health Tech
With the accelerated adoption of many new technologies, ECRI’s annual health technology hazards list has been transformed by the COVID-19 pandemic.
FDA Authorizes First At-Home Combination Diagnostic Test for COVID-19 and Flu
Patients will be able to collect their own samples and ship it to a Quest Diagnostics lab for analysis.
