Highlights 3

FDA Conference on the UDI Rule

The FDA held a conference on the proposed Unique Device Identification (UDI) rule on Sept. 18-19th in Orlando, Fl. The unique device identification system will require the label of medical devices and packages to carry a unique device identifier. Key Points Include:

  • Currently, there are non-standardized ID systems and UDI seeks to address this.
  • Timeframe for UDI Implementation: oProposed Rule came out July 10, 2012
    • Comments due by November 7, 2012
    • Final Rule due out 6 months after Comments- Anticipated May 2013
    • Implementation Timeframes are effective from the date the Final Rule is published.
  • Specific comments on, and solutions to, any potential issues with the Proposed Rule encouraged by FDA as the drafters may not understand all device phases.
  • A standardized date format for all medical devices (even those exempt from the UDI rule) is also proposed to ensure dates are clearly understood.
  • The UDI and corresponding information about the device will need to be submitted to a database (the Global Unique Device Identification Database) which the FDA will make publicly available.
  • UDI data may be used to support comparative effectiveness.
  • Possibility of UDI being used as part of Electronic Health Records (EHR) Meaningful Use Stage III.

O&P Exemptions?

One of these exceptions to the UDI labeling requirement includes Class I devices that FDA has by regulation exempted from the Good Manufacturing Practice requirements of 21 CFR 820, the Quality Systems Regulation. Even if the regulation requires that a Class I device remain subject to the general requirements concerning records (Sect. 820.180) and/or complaint files (Sect. 820.198) that device would nonetheless qualify for this exception.

Many O&P devices are classified as Class I. For these Class I devices the question then becomes are these devices exempt by regulation from GMPs? A list of Medical Devices Exemptions from the GMPs can be found here. It is important to understand that these exemptions apply to Class I devices, as Class II devices are NOT exempt from GMP requirements. For devices that do not fall under a specific exception the FDA is including a process for applying for case-by case labeling exceptions and/or alternatives to the standard UDI labeling requirements.

AOPA will be submitting comments on the proposed rule. To review the proposed rule please click here.