Senators Introduce the “Ensuring Safe Medical Devices for Patients” Bill Intended to Strengthen FDA’s Postmarket Surveillance of Medical Devices

By Carmelina G. Allis –

Amid recent reports alleging safety and effectiveness issues with a number of implant devices, a bipartisan group of Senators have introduced a bill entitled the “Ensuring Safe Medical Devices for Patients” (S. 2193).  This bill is intended to strengthen FDA’s postmarket surveillance of devices.  If enacted, this legislation would:

• Expand the Postmarket Risk Identification and Analysis System under Section 505(k)(3)(C) of the Federal Food, Drug, and Cosmetic Act (“FDC Act”) to devices.  This System currently applies to drugs, but would require that FDA establish and maintain procedures for, among other things, the active adverse event surveillance of devices.

• Require the agency to give priority in the Postmarket Risk Identification and Analysis System to Class II and Class III devices that are implantable, life-supporting or life-sustaining, or pose significant risk to users; and

• Amend Section 519(f) of the FDC Act to require that the agency implement the Unique Device Identification System no later than 1 year after the date on which final regulations are issued.  This bill also would require that the agency issue final regulations on a Unique Device Identification System no later than December 31, 2012.  The Food and Drug Administration Amendments Act of 2007 mandates that the agency establish a Unique Device Identification System that would require devices to bear a unique identifier that would identify the device through distribution and use, including information on the lot or serial number.  The agency has held public meetings and workshops on the matter (see here), but 5 years after the provision’s enactment FDA has yet to issue draft regulations. 

Overall, this proposed bill would strengthen FDA’s postmarket surveillance of medical devices and complement the Medical Device Reporting requirements in 21 C.F.R. Part 803.  It will also enhance the agency’s Sentinel Initiative, which was launched in 2008 to complement existing FDA systems for tracking adverse event reports of regulated products.