United States | Medical Devices
EMERGO SUMMARY OF KEY POINTS:
- US FDA has revised UDI direct marking requirements and deadlines for some non-sterile, Class I and unclassified medical devices.
- UDI policy changes were prompted to assist manufacturers manage compliance for devices in inventory and avoid potential device shortages.
The US Food and Drug Administration has revised its Unique Device Identification (UDI) regulation’s direct mark requirements and compliance deadlines in response to cost and inventory concerns raised by industry.
In new, immediately effective...
Source | Stewart Eisenhart
Nov 8, 2018