EMERGO SUMMARY OF KEY POINTS:

• US FDA is delaying GUDID submission requirements for some combination products by one year, to 2019.
• The delay impacts combination products that undergo premarket review by the Center for Drug Evaluation and Research (CDER).
• The latest GUDID submission data does not deviate from trends first identified by FDA in March 2018.

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.

Compliance delay for CDER-reviewed combination products

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.

Latest GUDID submission data

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:

• More than 80% of GUDID records pertain to Class II medical devices;
• More than 40% of GUDID records are for implantable devices, systems and accessories;
• More than 35% of product codes in GUDID are for orthopedic specialties, followed by dental (nearly 15%) and general and plastic surgery (more than 10%).

These figures are in line with those first reported by FDA in March 2018.

Learn more about US FDA UDI and GUDID regulatory requirements:

• Medical device UDI consulting and training
• Video overview: US FDA UDI requirements
• Whitepaper: Understanding US UDI regulations