The center is also hoping to move back into more normal review timelines next year.
The agency action includes all non-NIOSH-approved disposable respirators, including imported KN95s.
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.
The CCDS system was used to decontaminate compatible N95 respirators for multiple re-use.
The center is working to address the delays in meeting review timelines for product submissions.
Software continues to be a key factor in recalls, and this year the end of some EUAs may also contribute to an increase.
The test generates results within 20 minutes and can be used by adults and children over the age of two years old.
The record-high number of authorizations last year was a significant jump over 2019.
With the accelerated adoption of many new technologies, ECRI’s annual health technology hazards list has been transformed by the COVID-19 pandemic.
Patients will be able to collect their own samples and ship it to a Quest Diagnostics lab for analysis.