FDA is amending its proposed rule to establish a unique device identification (“UDI”) system, published on July 10, 2012 (see our previous post here), to meet the requirements of section 614 of the Food and Drug Administration Safety and Innovation Act ("FDASIA"), signed into law on July 9, 2012 (see our FDASIA summary and analysis here). 77 Fed. Reg. 69393 (Nov. 19, 2012). The amendment affects only implantable, life-supporting, or life-sustaining devices, primarily those that are not Class III devices or are not devices licensed under the Public Health Services Act ("PHS Act"), which are affected only as to the direct marking requirement.
FDASIA section 614 amends section 519(f) of the Federal Food, Drug, and Cosmetic Act ("FDC Act"), requiring FDA to implement “final regulations with respect to devices that are implantable, life-saving, and life sustaining” within two years of finalization of the UDI rule. The July 10 proposed rule required all Class III devices and devices licensed under the PHS Act to bear a UDI within one year of publication of the final rule. The effective date for those devices therefore meets the two year requirement in FDASIA and is not affected by this amendment.
To comply with the FDASIA requirements, FDA “is now proposing to require all other implantable, life-supporting, and life-sustaining devices (i.e., those that are not already subject to the 1-year effective date) to bear a UDI” within two years of publication of the final rule. 77 Fed. Reg. at 69394. In other words, any Class II, Class I, or unclassified devices that are implantable, life-supporting, or life-sustaining must also bear a UDI within two years of publication of the final rule, as opposed to three years as originally proposed. This is unlikely to have a practical effect on Class I devices, since few, if any, are implantable, and by definition they are not life-supporting or life-sustaining.
The proposed rule also requires direct marking of the UDI on certain limited categories of devices, including implantable devices. The direct marking requirement was to go into effect two years after the date on which the product was otherwise required to bear the UDI. For Class III implantables, this would have been three years after finalization of the rule, for Class II, five years, and for Class I, seven years. To comply with amended section 519(f), FDA is amending the proposed rule to require direct marking of all implantable devices, regardless of classification, within two years of finalizing the rule.
The biggest impact of this amendment will likely be on devices, primarily Class II, that are implantable, life-sustaining, or life-supporting, originally proposed to comply with the UDI requirements within three years of the final rule, and now required to comply within two years. Additionally, the amendment will affect implantable devices of all classes, primarily Class III and II, which now must bear a permanent marking one year and three years earlier than first proposed, respectively. Comments to the proposed rule closed on November 7, 2012. It is not clear when FDA will issue the final rule.