Continuous Glucose Monitor Apps Correction: Dexcom, Inc. Issues Correction for G7 Apps and ONE+ Apps due to a Software Design Error That Does Not Alert Users of Unexpected Sensor Failure

ABBOTT PARK, Ill., Nov. 24, 2025 — Abbott has initiated a medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the United States after internal testing determined that some sensors may provide incorrect low glucose readings.

This draft guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints (a comparative efficacy study or CES) intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product.

Consumer articles about over-the-counter and prescription drugs.

This technical specifications document represents the Food and Drug Administration’s (FDA’s) current thinking on this topic.

Biocon Biologics Limited – 09/03/2025. Country: India. Record Type: 483

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/10/2025
Short Title (70 char) MedisourceRx. Los Alamitos, CA. 483 issued 06/10/2025
FEI Number 3013316698
Firm Name MedisourceRx
Record Type 483
State CA