The September 2013 FDA Final Rule on UDIs for medical devices is now law!
So what does this mean for Medical Device industry?
It means that imminently, medical device manufacturers will have to upgrade their labeling and packaging systems along with their data management capabilities in order to stay compliant with incoming regulations and this is independent of creating systems to meet the demands of electronic regulatory reporting to the FDA and EMHA agencies. |
How can Portford Solutions help me with my compliance needs?
On the whole, there was little concentrated information on the state of devices provided to the patient population by the industry. Simple marketing data such as what company makes what device; sales figures of each individual implants per medical device companies; or the number of procedures done for each implant each year are readily available. Key safety and efficacy information is not readily available to the companies, regulatory agencies and the communities they serve. Industry watchdogs are concerned that little information is gathered in any one place about the potential dangers and flaws of these devices, or the complications that occur due to their implantation procedure. Revised regulations are forthcoming, to be implemented over time.
At Portford, our stated systems development direction for both core software and services will fill this shortcoming by providing all the requirements for medical device tracking, patient clinical data collection and regulatory reporting. In addition we will be offering advanced data analytics and predictive analysis integrated into our workflow-based medical device tracking software to report on trends in device stability, performance and providing early detection of problems with devices before they become an issue for the companies, regulatory agencies and the patient population. |
So what exactly is the “Law” and what isn’t
There has been a great deal of confusion about what would be imposed by the Patient Protection and Affordable Care Act (PPACA) – (a.k.a., “Obamacare”) HR 32001 (1) passed in 2010. Think of the law as having many distinct parts. From the title alone you have the core components of Patient Protection (part of the law governing such things as increasing quality and access to information) and Affordable Care
At Portford, our stated systems development direction for both core software and services will fill this shortcoming by providing all the requirements for medical device tracking, patient clinical data collection and regulatory reporting. In addition we will be offering advanced data analytics and predictive analysis integrated into our workflow-based medical device tracking software to report on trends in device stability, performance and providing early detection of problems with devices before they become an issue for the companies, regulatory agencies and the patient population. |
Covering both labeling and the Global UDI (GUDID) database, manufacturers need to assess their current technical capabilities – both hardware and software – and work out how much they need to do in order to comply. Within the European market, the European Commission also announced their intention to follow suit, potentially as soon as this year (2014) (2). Compliance is to begin for some companies at the end of 2014 and all companies are to be fully compliant by 2020. Many Class I devices are expected to be exempt.
So what do I have to do?
The label of a device is to bear a unique identifier, unless an alternative location is specified by the U.S. Food and Drug Administration (FDA) or unless an exception is made for a particular device or group of devices.
The unique identifier to be able to identify the device through distribution and use.
The unique identifier to include the lot or serial number, if specified by FDA.
By the FDA adoption of the UDI system it is expected that the central requirement will create a common vocabulary for reporting and enhance electronic tracking abilities. Currently, analysis of adverse event reports is limited by the fact that the specific devices involved in an incident are often not known with the required degree of specificity. Without a common vocabulary for medical devices, meaningful analysis based on data from existing voluntary systems is problematic. Reliable and consistent identification of medical devices would enable safety surveillance so that the FDA and manufacturers could better identify potential problems or device defects, and improve patient care.
The UDI is expected to improve patient safety (in part by helping to identify counterfeit products and by improving the ability of staff to distinguish between devices that are similar in appearance but serve different functions), facilitate and improve the recall process, and create efficiencies within the medical system.
In the most basic format, the UDI is a coded number registered with standards organizations, and would incorporate a variety of information, including (but not limited to) the manufacturer of the device, expiry dates, the make and model of the device, and any special attributes that the device may possess. In a medical sense, “device” refers to any product that is not pharmaceutical in nature, and while the FDA have been given approval to exempt some devices, FDA’s VP of the UDI Program, Jay Crowely (who was responsible for implementing the UDI requirements in the Act), has expressed an intent to apply the UDI to “everything until somebody gives us good reason not to”, (excluding devices which won’t need identification) (3).
So when do we have to act to meet compliance to the law?
Since the passing of the Act, there have been calls for the FDA to publish a timeline for the implementation of the UDI and that published timeline for the FDA website is presented herein:
FDA Compliance Dates for UDI Requirements
The table below outlines key compliance dates in the UDI final rule.
1 year after publication of the final rule (September 24, 2014) |
The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices must be submitted to the GUDID database. § 830.300. A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014. Class III stand-alone software must provide its UDI as required by § 801.50(b). |
2 years after publication of the final rule (September 24, 2015) |
The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18. A device that is a life-supporting or life-sustaining device that is required to be labeled with a UDI must a bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. § 801.45. Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI as required by § 801.50(b). Data for implantable, life-supporting, and life-sustaining devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300. |
3 years after publication of the final rule (September 24, 2016) |
Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45. The labels and packages of class II medical devices must bear a UDI. § 801.20. Dates on the labels of these devices must be formatted as required by § 801.18. Class II stand-alone software must provide its UDI as required by § 801.50(b). Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300. |
5 years after publication of the final rule (September 24, 2018) |
A class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45. The labels and packages of class I medical devices and devices that have not been classified into class I, class II, or class III must bear a UDI. § 801.20. Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by § 801.18. Data for class I devices and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI must be submitted to the GUDID database. § 830.300. Class I stand-alone software must provide its UDI as required by § 801.50(b). |
7 years after publication of the final rule (September 24, 2020) |
Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45. |
What isn’t the law? Compliance dates for all other provisions of the final rule. Except for the provisions listed above, FDA requires full compliance with the final rule as of the effective date that applies to the provision.
Well, what was in the specification of the original PPACA was the creation of a National Medical Device Registry (NMDR) but that was later dropped during the negotiations as being too intrusive at the time to be imposed upon the MedTech industry including biotech, pharma and medical devices industries and was dropped due to industry pressure related to adherence to the initial law. It is expected to be included in one of the next revisions of the PPACA. The task force for continued investigation already exists and they are working on proposals acceptable to industry, academia and regulatory professionals (4).
National Medical Device Registry (NMDR) – Rapidly Changing Regulatory Environment
Initially as proposed in HR 3200, a national medical device registry was to be established by the Department of Health and Human Services (HHS). Within the registry, devices would be listed by type, model and serial number, or some other unique identifier.
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The registry was intended to assist HHS in evaluating the safety and effectiveness of all implantable medical devices, including all orthopedic, neurovascular, cardiovascular, ophthalmic and dental implants. It would link data provided by manufacturers to the U.S. Food and Drug Administration with outcomes data drawn from many sources, including Medicare claims data, electronic medical records and adverse event reports. The registry data and analyses would be stripped of patient information and ultimately made available to the public and the Centers for Medicare amd Medicaid Services (CMS). |
The NMDR also authorized HHS to require device makers to submit “such other information as is necessary to facilitate post-market assessments of device safety and effectiveness and notification of device risks” on an annual basis.
While the registry was not ultimately included in the final version of the bill, its proposed creation is an indicator of the potential future government role and direction for tracking medical devices. It is expected that device companies will be inclined to adhere to best practice and embrace many elements of the proposed registry concept for their own use. The industry has adopted the standard for device identification that was originally proposed of its own volition.
What all this boils down to is compliance to the new regulations can occur in stages through 2020 to allow our industry to come into full compliance. Even with a published timeframe for UDI regulation compliance, there are still other regulations and guidance in the works that we have to be vigilant for. After all, the most respected industry trends publishing group, Emergo, in their past few years’ of reporting on the annual State of the Industry for the Medical Device industry find that the biggest challenge faced by the consensus of industry experts is the “Changing Regulatory Environment”.
Biggest Challenges Faced by Medical Device Companies – By Company Size
(Source: Emergo 2014 Survey – segmentation; company size by number of employees (5))
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References
(1) http://www.gpo.gov/fdsys/pkg/BILLS-111hr3200ih/pdf/BILLS-111hr3200ih.pdf(2) http://www.raps.org/regulatoryDetail.aspx?id=8350
(3) Joch, Alan (October 2008). "A device by any other name". Materials Management in Health Care 17 (10): 16
(4) http://www.mdepinet.org/index.php/registry-task-force/
(5) http://www.emergogroup.com/resources/research/annual-medical-device-industry-survey
