(2 JUN 2017, Silver Spring, MD) FDA extended the UDI Compliance deadline for manufacturers of certain lower risk Class I and Unclassified medical devices. According to the “Dear Manufacturer” Letter, FDA did this in response to the overwhelming feedback from manufacturers from the previous deadlines as well as logistical issues for procedure trays containing implants and other situations which had not been completely thought out. To deal with this change, FDA plans to issue a Guidance in the near future in which enforcement discretion and the new compliance dates will be formalised.
Based on the Letter, these lower risk Class I and unclassified devices will have to meet UDI labeling, GUDID data submission and related rules by September 24, 2020, and the direct mark requirements will have to be met by September 24, 2022. The new deadlines do not apply to Class I or unclassified devices that are implantable, life-supporting or life-sustaining.