During this week’s Consumer Electronics Show, FDA Principal Deputy Commissioner Amy Abernathy talks about lessons learned from the pandemic and 2021 goals.
The exemption reduces the regulatory burden on the medical device industry—including the time and costs involved in preparing, submitting and responding to requests for additional information.
Participate in our new survey and have a chance to win complimentary access to the Computer Modeling & Simulation Virtual Conference on January 27–28, 2021.
CAPA consistently remains a top reason for FDA’s 483 observations, usually due to inadequate processes or inconsistent adherence to regulatory requirements.
Patients will be able to collect their own samples and ship it to a Quest Diagnostics lab for analysis.
Top reasons for recalls include software, quality and parts issues.
Lucira Health’s single-use molecular test kit will be available for prescription home use in people age 14 and older.
Part three of this series discusses the key defenses available to each element of a lawsuit against providers and labs.
To avoid delays in timelines, companies should develop IFU cleaning instructions with the worst-case clinical use and contamination method in mind.
The serology test is the first of its kind to detect neutralizing antibodies from a recent or prior SARS-CoV-2 infection.