FDA / Regulatory News
The Senate confirmed Stephen Hahn as the next FDA commissioner
On the device front, Hahn will be taking over FDA as it grapples with a number of device issues including:
- Duodenoscope safety (Duodenoscopes are hollow, flexible, lighted tubes that allow doctors to see the top of a patient’s small intestine, or duodenum)
- Long-term device material compatibility
- How to regulate rapidly changing software as a medical device
EU MDR compliance delay for certain Class I devices
Three different groups of medical devices in Class I will get an additional four years (until May 26, 2024) to come into compliance with the new regulation. These are devices (large volume and low risk) that are in full compliance with the current Medical Device Directive (MDD) and may remain or be placed on the market:
- Reusable surgical instruments
- In sterile conditions
- Have a measuring function
European medical device regulation timetable:
- EU MDR (Medical Device Regulation) – May 26, 2020
- Eudamed (database which will be used to monitor the safety and performance of devices and is part of the EU’s MDR) – May 26, 2022
- IVDR – (In Vitro Diagnostic Regulation) – – May 26, 2022
Product Recalls and Issues
Dexcom Follow app server outage
Dexcom Follow app server outage left many parents of diabetic children without their usual ability to remotely track blood sugar levels from continuous glucose monitors.
A service that enables data streaming and alerts to parents, spouses or other caregivers’ smartphones — went down the weekend following Thanksgiving and was not entirely resolved until the middle of the following week.
The ultimate concern is that a person’s blood glucose levels drop dangerously low, while sleeping or otherwise, without anyone serving as a backup for them to realize it and take corrective steps.
The FDA is aware of the issue and will be working with Dexcom to remediate it. The agency granted marketing authorization to the Dexcom cloud software in October 2014.
