Aug 17, 2018
EMERGO SUMMARY OF KEY POINTS:
The US Food and Drug Administration is pushing back Unique Device Identification (UDI) compliance deadlines for certain combination products by one year, to September 24, 2019. The agency has also provided updated information on GUDID entries as of August 2, 2018.
According to a letter from the FDA, the delay affects drug-device and biologic-device combination products that undergo premarket review by the agency’s Center for Drug Evaluation and Research (CDER); such devices had faced a September 24, 2018 deadline for meeting UDI labeling and Global Unique Device Identification Database (GUDID) requirements, but now have until September 2019 to comply with GUDID rules. (The September 2018 deadline for UDI labeling requirements still applies to these devices.)
“We are deploying enhancements to GUDID to better accommodate data submissions of combination products that are reviewed by CDER and contain device constituents,” explains the letter from FDA.
FDA also recently published new data on GUDID records and submissions. As of August 2, 2018, about 1.8 million medical device records have been submitted into the database.
Additional data published by FDA include:
These figures are in line with those first reported by FDA in March 2018.
EMERGO SUMMARY OF KEY POINTS:
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EMERGO SUMMARY OF KEY POINTS:
EMERGO SUMMARY OF KEY POINTS: