Jan 15, 2018
EMERGO SUMMARY OF KEY POINTS:
The US Food and Drug Administration has formally pushed back some Unique Device Identification (UDI) compliance deadlines by two years for qualifying low-risk medical devices.
New guidance from the regulator establishes deadlines initially discussed in June 2017 according to coverage by Emergo. The extended deadlines apply to the following cases:
As noted by FDA in previous discussions, these UDI compliance extensions do not apply to devices with implantable, life-supporting or life-sustaining features.
EMERGO SUMMARY OF KEY POINTS:
Medical device regulators at the US Food and Drug Administration have notified labelers of some Class II devices that their deadline for Unique Device Identification (UDI) compliance has been extended to September 2018.