- FDA released a guidance document Friday updating its policy on unique device identification (UDI) requirements for Class I and unclassified devices.
- The agency said it does not intend to enforce UDI direct mark requirements until Sept. 24, 2022 for devices whose compliance date is Sept. 24, 2020, with the exception of life-supporting or life-sustaining devices.
- FDA also does not intend to enforce UDI direct mark requirements for devices that are non-sterile, were manufactured before Sept. 24, 2022 and remain in inventory but bear a non-UDI mark from which the full UDI may be made available.
FDA's unique device identification system is being phased in over seven years. When fully implemented, the system is expected to improve reporting of adverse events so that problem devices can be identified and corrected faster. With a standardized identifier, device manufacturers and healthcare facilities should be able to better manage recalls.
The 2013 rule requires that the UDI identify the specific model and key information about its production, such as date of manufacture and serial number. Compliance dates for Class II and III devices are already in place.
FDA said it is extending the compliance date for Class I and unclassified devices in response to industry concerns that reworking devices in inventory to comply with UDI requirements would be a costly burden. The new guidance is effective immediately and supersedes guidance issued in January.
"By changing the previous policy, there may still be some achievement of the benefits of UDI for devices that have remained in inventory while reducing the risk that industry will choose to avoid the cost of remediation by discarding inventory and potentially creating device shortages," the agency said in a statement.
FDA said the guidance document is available for comment through electronic submission at www.regulations.gov even though the guidance in effect immediately.