Inside HSCA: FDA Clarifies Timeline for Implementation of Proposed UDI System – Amendment Consistent with HSCA Recommendations

On November 19^th, the FDA issued a clarification of the timeline for implementation of the proposed unique device identification (UDI) system for medical devices. Specifically, in a proposed amendment to the original July 10^th UDI proposal, the FDA is attempting to incorporate the time requirements included in the FDA Safety and Innovation Act (FDASIA) relative to the roll out of the labeling and direct marking requirements for devices that are implantable, life-saving or life-sustaining.

The FDASIA requires these devices to be UDI-compliant within two years of the final regulations. This requires the FDA to modify its original timeline because some Class II and Class I devices are implantable, life-saving, or life-sustaining, and these classes, as a whole, were originally proposed to be rolled out 3 and 5 years after the final rule, respectively. The FDA clarification is good news for patients and for HSCA and others whose vision is a more efficient and deliberate phase-in for all devices, particularly those devices that have compelling patient safety propositions.

While the FDA is modifying its own proposal, the changes, required by the FDASIA, are consistent with the proposed timeline offered by HSCA during the open comment period that closed November 7^th. Rather than the original seven year phase-in (where Class III devices would come online compliant with the UDI labeling requirement within one year of the final regulations, Class II devices within three years, and Class I devices within five years, with each class having an additional two years to meet the direct marking requirements), the FDA would now require those Class II and Class I devices that are implantable, life-saving, or life-sustaining to be compliant within two years of the final regulation. All such devices would also have to meet direct marking requirements within this timeframe as well. The FDA leaves in place the one year requirement for Class III labeling.

HSCA has recommended a three year phase-in, with all Class III devices within the first year, all Class II devices no later than the second year, and all Class I devices no later than the third year, but with all implantable, life-saving, and life-sustaining devices within the two year requirement of the FDASIA. The proposed amendment offered by the FDA now aligns with HSCA recommendation.

HSCA bases its timeline on the assumption that a labeler’s duty to bring devices into compliance starts with the first year of the final regulation. Just as the FDA’s proposal asks for all Class III devices to be labeled with a UDI by year one, HSCA’s timeline expects all labelers to meet that same year-one timeframe for their highest class devices. So for a labeler with only Class II and Class I devices, within the first year of the final regulation those Class II devices would have to be compliant.

The FDA clarification sends a strong signal that patient safety plays an important role in fashioning a phase-in for all devices. HSCA also applauds the FDA’s determination that this clarification in no way extends the November 7^th comment deadline.

“FDASIA requires a final UDI rule not later than six months after the close of the comment period. FDA and HSCA agree that the clock has been running since November 7^th, and the group purchasing industry is hopeful that the final regulations will offer a more expedited timeline within the three year window we have proposed,” said HSCA President Curtis Rooney.