Regulatory Focus™ > News Articles > Proposed Bill Would Mandate Passage of Device Identifier, Data Collection

Proposed Bill Would Mandate Passage of Device Identifier, Data Collection

Posted 11 May 2012 | By Alexander Gaffney, RAC 

A new piece of legislation introduced in the House of Representatives by Rep. Lois Capps aims to expand postmarket tracking of medical devices and implement a mandate for the passage of a Unique Device Identification (UDI) rule by the end of 2012.

The bill, the Sentinel Assurance for Effective Devices (SAED) Act of 2012, was referred to the Energy and Commerce Committee on 7 May 2012.

SAED would amend section 522 of the Federal Food, Drug and Cosmetic Act (FD&C Act), which establishes a postmarket risk identification and analysis system, to apply to most medical devices. The system currently only applies to pharmaceutical products.

"Notably absent, however, is what FDA would do with the data obtained," writes FDA Law Blog. "Simply gathering data without clear plans for how to use the information may impose resource burdens without commensurate benefits."

Capps' bill says the US Food and Drug Administration (FDA), in implementing this legislation, should focus primarily on Class II and Class III medical devices, which convey the most risk to patients in a postmarketing setting.

The legislation would also mandate FDA devise a UDI system for Class III medical devices no later than 31 December 2012. FDA would also be required to implement such a system within a year of promulgating a final regulation for Class III devices, within three years for all Class II medical devices, and within five years for all other medical devices.

Current proposed rules for the passage of a UDI have held up at the Office of Management and Budget (OMB) for months. The rule would require each medical device to have a unique identification code to allow FDA to track and trace all medical devices. The rule was mandated under the FDA Amendments Act of 2007, but no legal deadline for its implementation was established, allowing OMB to stall indefinitely.

Read more:

Sentinel Assurance for Effective Devices (SAED) Act of 2012

FDA Law Blog - House Bill Introduced to Include Medical Devices in the Postmarket Risk Analysis and Identification System

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