On May 7, 2012, Representative Lois Capps introduced the “Sentinel Assurance for Effective Devices Act of 2012” (H.R. 5341), many elements of which were also included in the House of Representatives Energy and Commerce Health Subcommittee user fee bill (see here). The primary purpose of the bill seems intended to allow FDA to more regularly collect, review, and trend adverse event data for medical devices. The bill accomplishes this in two ways: First, it would amend the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to include medical devices in the postmarket risk analysis and identification system currently applicable only to drugs. Second, it would require FDA to issue a final rule regarding a unique device identification (“UDI”) system by December 31, 2012.
With regard to the first purpose, the bill would amend section 505(k)(3)(C) of the FDC Act to expand the postmarket risk identification and analysis system established under that section to include and apply to devices. This would require FDA to establish and maintain procedures for risk identification and analysis based on electronic health data, and to provide for “active adverse event surveillance” using federal health-related electronic data and private sector health-related electronic data, such as medical device utilization data, health insurance claims data, and procedure and device registries. It would also require FDA to identify trends and patterns regarding the data accessed by the system, and to create reports concerning adverse event trends, patterns, incidence, and prevalence. The bill states that FDA should give priority to postmarket risk identification and analysis with respect to class II and class III devices.
The second part of the rule is to encourage FDA to finally issue in final form the UDI rule it was mandated to promulgate in the Food and Drug Administration Amendments Act of 2007. When implemented, (1) the label of a device will bear a unique identifier, unless an alternative location is specified by FDA or unless an exception is made for a particular device or group of devices; (2) the unique identifier will be able to identify the device through distribution and use; and (3) the unique identifier will include the lot or serial number if specified by FDA. These features are intended to make devices easier to track for purposes of adverse event and recall tacking. The Sentinel Assurance Act would require FDA to implement the UDI system for class III devices within one year after the date final regulations are issued; within three years for implantable, life-sustaining, and life-supporting devices; and within five years for all other devices.
This bill is undoubtedly one more attempt to obtain information about the safety (or risk) of medical devices. Notably absent, however, is what FDA would do with the data obtained. Simply gathering data without clear plans for how to use the information may impose resource burdens without commensurate benefits. Presumably it would be up to FDA to determine how best to use this information. Hopefully, this determination will include input from stakeholders to assure it is appropriately and meaningfully used.