FDA Asks Glucose Monitor Hackers For Gap Analysis Report
This article was originally published in The Gray Sheet
Executive Summary
Citizen device hacking group NightScout says the agency wants to allow them to continue their work but wants to see a report on measures to log and report any user confusion, technical problems or adverse events and meet again in three months to discuss. The group, which modifies DexCom glucose receivers to track real time data over the internet, met with FDA Oct. 8.
You may also be interested in...
US FDA Warns Of Potentially Deadly DIY Diabetes Devices, Algorithms
As the use of "hacking devices" is gaining in popularity among diabetes patients, the US Food and Drug Administration is warning against using products not approved by the agency. Regulators say the practice almost killed one patient.
US FDA Gene Therapy Accelerated Approval Guidance Will Describe ‘Buckets’ Of Use Scenarios
Forthcoming guidance is expected to describe areas of “low-hanging fruit” and those that are more challenging for use of the expedited pathway, Center for Biologics Evaluation and Research Director Peter Marks said.
FTC Early Findings In PBM Investigation Coming By Mid-Summer, Chair Kahn Says
The agency is also poised to announce another development in its scrutiny of the drug patents listed in the FDA’s Orange Book.