FDA Accelerates Implementation Deadline of UDI Rule for Certain Higher-Risk Devices
Posted 19 November 2012 | By
The US Food and Drug Administration (FDA) has unveiled a new amendment to its proposed unique device identification (UDI) rule that would accelerate the implementation schedule of the rule for certain types of medical devices.
The rule has long been under consideration by both FDA and stakeholders. It was required under the 2007 FDA Amendments Act (FDAAA), and was intended to standardize how medical device products are tracked and traced by requiring all devices be marked with an identification number or labeling system.
FDA released a draft version of the UDI rule for consideration on 10 July 2010, but it was held up by the Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA) under somewhat mysterious circumstances for well over a year.
On 3 July 2012, FDA released its proposal for the UDI system and a tracking database, known as the Global Unique Device Identification Database (GUDID), which would be used to keep track of all devices' unique identifiers. The system opted for a phased-in approach, with rules coming into effect 1, 3, 5 and 7 years after the publication of the final UDI rule depending on the risk-profile of the device. Riskier devices would be required to comply with the law more quickly, while lower-risk devices would have more time.
Changes under FDASIA
Days after the release of the proposed UDI rule, President Barack Obama signed into law the FDA Safety and Innovation Act (FDASIA), a successor bill to FDAAA that renewed user fee bills and called for a number of reforms at FDA.
Among its many requirements, FDASIA requires FDA to release its final UDI rule to the public no later than 31 December 2012. Public comments on a proposed version of the rule were due by 7 November 2012, but FDA may struggle to accommodate the deluge of comments it received on the rule-249 in all. The agency has historically sought to address all comments (though often by condensing them into common complaints) in the final guidance, which is a time-consuming affair.
One notable caveat to the 31 December 2012 requirement: FDA may exempt particular types of devices from the UDI rule. Under FDASIA, certain medical devices-implantable, life-saving, life-supporting or life-sustaining medical devices-will be given two years to comply with Section 519(f), or the UDI rule, of the Federal Food, Drug and Cosmetic Act).
Similarly, all manufacturers will be required to submit identification data to the GUDID within two years of the publication of the final rule.
FDA notes that while this sounds like an extension, the two-year exemption actually accelerates the pace of compliance relative to FDA's original intend. Class III (high risk) implantable medical devices were originally to be granted three years to comply with the rule; Class II devices were to be given five years; Class I (low-risk), seven. Under the new proposal, all will be required to comply in two years.
FDA estimates the total cost of compliance with the rule will now be between $540 million and $608 million based on 2010 dollars.