Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
In particular, new FDA requirements around modifying IVDs could lead labs to push for IVD vendors to validate their tests across a wider variety of use cases.
Former Executive at COVID Test Kit Firm Sentenced to 77 Months for Embezzling $1.85M
Dennis Haggerty Jr. will serve the sentence following his current 57-month sentence for defrauding a hospital out of $2.5 million for undelivered respiratory masks.
FDA Details Policy on Predetermined Change Control Plans and Modification of Medical Devices
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The agency issued a draft guidance to detail its thinking on the use of PCCPs to update medical devices, but some fear its policy may be more restrictive than hoped.
Fast MDx Gets CE-IVDR Mark for High-Throughput Molecular Platform
The London-based social enterprise plans to officially launch its fully automated qPCR-based test system later this year.
UltraDx Bio Receives Chinese Clinical Registration Approval for UD-X Immunoassay Analyzer
With the approval, the UD-X analyzer, which uses Quanterix's single-molecule array technology, can be used for clinical applications in China.