FDA Flags Unauthorized Devices for Diabetes Management
The FDA warned that some manufacturers have been marketing illegal diabetes management devices, including automated insulin dosing systems and insulin pumps. Components used with other devices, such as continuous glucose monitors, have also been unlawfully marketed, the agency said.
The products haven’t been evaluated by the FDA for safety and effectiveness and can potentially pose serious risks to diabetic patients, such as inaccurate glucose level readings or unsafe insulin dosing.
Using unapproved or unauthorized devices for managing diabetes could lead to serious injury or death as their safety and effectiveness hasn’t been confirmed by the FDA, the agency said in a safety notice.
“The FDA will continue to closely monitor reports of adverse events associated with the use of unauthorized devices for diabetes management and will keep the public informed if new information becomes available,” the agency said.
TÜV SÜD Gains Second EU MDR Designation
TÜV SÜD Product Service has become the second notified body to be accredited under the EU’s new medical device regulation (MDR), meaning the product certifier is now authorized to provide certification services under the new MDR.
European device groups such as the European Association for Medical Devices of Notified Bodies (Team-NB) are alarmed at the shortage of notified bodies to conduct audits and certify devicemakers in time to comply with the new regulations. In January, Team-NB said the May 2017 to May 2020 implementation period was too short, given that many details for both manufacturers and notified bodies are still under discussion (IDDM, Jan. 4).
In April, MedTech Europe warned that the EU’s new regulatory system for devices won’t be ready on time (IDDM, April 26).