Jul 28, 2022

The US Food and Drug Administration has exempted low-risk medical devices considered consumer health products from some Unique Device Identification compliance requirements in accordance with least burdensome principles.

GUDID exemptions for “consumer health products”

According to updated guidance from FDA on its UDI and Global Unique Device Identification Database (GUDID) policy for Class I and unclassified devices, the agency has exempted devices qualifying as consumer health products from GUDID submission requirements; however, these devices must still bear UDI data on their labeling and packaging.

FDA defines consumer health products as “510(k)-exempt class I devices that are sold directly to consumers over-the-counter in brick-and-mortar and/or online stores.”

Delayed GUDID deadlines for other Class I devices

The FDA guidance also identifies Class I devices that do not meet the agency’s definition of consumer health products. Although not exempt outright from GUDID submission requirements, these devices have been granted compliance deadline extension, to December 8, 2022. Affected device types include:

  • Class I reserved devices, which require 510(k) clearance for US market authorization
  • Restricted devices, which may be sold, distributed or used only via prescription or other legally licensed administration
  • Implantable devices, which are placed within the human body and remain implanted for no less than 30 days
  • Life-supporting or life-sustaining devices, which play a role in restoring or continuation of a vital bodily function
  • Devices distributed to healthcare facilities/professionals, which are intended for use only by healthcare personnel, and are either reusable, reprocessed or intended for wound care

It should be noted that Class I devices the FDA considers Life-supporting or life-sustaining devices do not qualify for the December 2022 GUDID compliance deadline extension. However, the deadline extension for GUDID submissions does also apply to unclassified devices, which usually require 510(k) premarket notification from US regulators and have been commercialized in the US since before the Medical Device Amendments took effect in 1976.

Learn more about US FDA medical device and UDI regulations at Emergo by UL:

Author

  • Stewart Eisenhart

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