Regulatory Focus™ > News Articles > Extension Proposed for Comment Period on Important Medical Device Rule

Extension Proposed for Comment Period on Important Medical Device Rule

Posted 14 September 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is proposing to extend the comment period on a proposed rule that would overhaul the way medical devices are overseen by regulators, it has announced.

In July 2012, FDA released a long-awaited rule on a Unique Device Identification (UDI) system which would require most medical devices to carry an identification number and/or barcode capable of tracing the device back to its point of origin.

Though the rule was mandated under legislation passed in 2007, it was held up for years by industry concerns and, most recently, the Office of Management and Budget, which sat on the rule without comment for more than a year before quietly approving it.

In releasing the proposed rule, FDA originally requested a 60-day comment period for it to collect information from the public and industry. However, in a 14 September Federal Register posting, FDA said it had received requests for an additional two months' time in which to comment on the proposal.

"Each request conveyed concern that the current 60-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to the information collection," FDA explained.

 The original UDI comment period expired on 10 September 2012, but FDA said it has requested from the Office of Management and Budget (OMB) a 45-day comment period extension lasting until 25 October 2012.

"The agency believes that a 45-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues," FDA wrote. 

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