As many of you are already aware, our friends from the agency issued the final rule for a Unique Device Identifier (UDI) System in September. In fact, the final rule comes into full play on the 23rd of December, with parts of the rule already required, effective the 24th of October 2013, e.g., §801.55, §830.10, §830.100, §830.110, §830.120, and §830.130. Before you even ask, Dr. D did not make a typographical error, 21 CFR, Part 830 is the newly introduced FDA regulation for UDI. It actually makes for some interesting reading. Surprisingly, it really does not make a whole bunch of sense attempting to “inveigh” (look-it-up) against a regulation that actually has some significant merit. That being said, the doctor hopes you enjoy this week’s guidance.
So what is so great about UDI?
The doctor thinks that we are probably all in agreement when first and foremost; a fully implemented and integrated UDI system will allow the agency to obtain a more accurate picture when it comes to reporting, reviewing, and the subsequent trending and analysis of adverse events. Can you say MDRs, although important now to the US device industry, will grow in significance when it comes to reporting serious incidents? The agency will be able to employ the UDI to ensure action can be quickly taken against medical devices that are less than safe and effective in their intended use. Can you say Recall (Dr. D’s favorite six-letter word)?
Additionally, successful implementation of the UDI system will hopefully drive: (a) a reduction in medical errors due to the enhanced ability to correctly identify a device; (b) the effective linking of device information to electronic health records, resulting in an enhanced approach to post-market surveillance; (c) an improvement in the effectiveness of product recalls; (d) a reduction in device counterfeiting activities; and (e) the eventual creation of a global UDI system (the doctor can dream).
One of the doctor’s concerns relates to the FDA’s work as being too US device-industry centric. Now granted, the agency is charged with protecting the public health of those of us residing in the good-ole U.S. of A. However, it sure would be nice to pursue a truly global approach to UDI that works for the all regulatory bodies scattered around the planet. No, Dr. D has not fallen off his rocker; and the doctor does not particularly like singing Kumbuya. However, a truly global approach to UDI will require buy-in from everyone. Even a subset of everyone such as: (a) Health Canada; (b) MFDS – Korea; (c) TGA – Australia; (d) ANVISA – Brazil, (e) COFERPRIS – Mexico; (f) CFDA – China; and the Competent Authorities – Europe would be one giant step toward UDI utopia. However, with the sudden demise of the ICH in the not too distant past, utopia is probably just going to result in nothing more than that proverbial pipe dream.
Important dates for compliance
The following dates are immensely important when it comes to UDI compliance for Q4-2013 and beyond. For starters, December 18th is extremely important. It is strongly recommended that all device industry professionals read the Medical Device Summit and in particular this article before Dr. D’s next blog article is posted on the 18th of December (just kidding, the doctor hopes you enjoy his attempts at levity).
September 24, 2014
Come the fall of next year, less than 12 months away, all labels for most Class III devices will need to contain a UDI and be formatted in accordance with §801.20. Additionally, the date format will need to be in accordance with §801.18. Furthermore, data for Class III devices will need to be submitted to the GUDID database. For device establishments that are slow on the uptake, a one-year extension, delaying compliance, may be requested in accordance with §801.55. However, you better act quickly as all requests must be submitted prior to June 23, 2014. Oh yes, please do not forget about the software requirement. Class III stand-alone software must provide its UDI as required by § 801.50(b).
September 24, 2015
Looking a little further into the future, the labels and packaging of implantable, life-supporting, and life-sustaining devices will need to have their UDI affixed by 24 September 2015. Similar to the previous year’s requirement, formatting of the dates on the label will be required in accordance with §801.18. Additionally, the device will be required to contain a permanent mark if the device is slated for reuse and subsequent reprocessing. Data associated with implantable, life-supporting, and life sustaining will also need to be submitted to GUDID in accordance with §830.300.
September 24, 2016
Moving even further into the future, Class III devices labeled with a UDI will also require a permanent marking on the device if the device is intended to be reused or reprocessed. By 24 September 2016, Class II devices will be required to have a UDI-formatted label in accordance with §801.20 and a date formatted in accordance with §801.18. Software categorized as Class II must also be identified with a UDI, in accordance with §801.50. Finally, Class II devices required to contain a UDI will also be required to be loaded into the GUDID database.
September 24, 2018
A half a decade from now, five years for those of you that are decade challenged; Class II devices that are required to have a UDI and are intended for reuse and subsequent reprocessing must contain permanent marking on the device, in accordance with §801.45. At this point in the future, the UDI fun commences for Class I devices, in accordance with §801.20. Similar to requirements delineated in previous years, Data for Class I devices will be required to be loaded into the GUDID database.
September 24, 2020
In the seventh year of the UDI journey, Class I devices intended for reuse and subsequent reprocessing will require a permanent mark on the device itself in accordance with §801.45. In a utopian medical device world, hopefully the entire planet will be onboard with UDI come 2020. Only time will tell.
Takeaways
For this week’s guidance, the doctor will leave the readers with just one takeaway. UDI is finally upon us so embrace the change and begin working toward compliance. Is UDI going to be expensive for device manufacturers? Absolutely! Changing product labeling and affixing permanent markings onto devices is an expensive proposition. However, if the end result of UDI can actually save lives, the money spent will be well worth the investment.
In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.
References:
- Code of Federal Regulation. (2013, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).
- UDI rule and GUDID guidance. (2013, September). FDA Website. Retrieved December 4, 2013, from udi@fda.hhs.gov
- Unique device identifier. (2013, September). The Federal Register. Retrieved December 6, 2013, from https://www.federalregister.gov/articles/2013/09/24/2013-23059/unique-device- identification-system.
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