UNIQUE DEVICE IDENTIFICATION U.S. FDA. March 2014

Transcription

1 UNIQUE DEVICE IDENTIFICATION U.S. FDA March 2014

2 Introduction The Food and Drug Administration (FDA) has released a final rule requiring most medical devices distributed in the United States to carry a unique device identifier, or UDI. It also applies to certain combination products that contain devices. Reference: deviceregulationandguidance/uniquedeviceidentification/ default.htm Definition A unique device identifier is a code placed on each applicable medical device and information entered into a global unique device identifier database (GUDID) which identifies specific device and production information about each device placed on the U.S. marketplace. Scope and Requirements Per FDA, device identification consists of the following, albeit not all classes require item 2, production identifier: 1. Device identifier: The proprietary/trade/brand name of the device 2. Production Identifier: Variable information, such as the lot or batch, the serial number, expiration date, the date of manufacture, and, for human cells, tissues, or cellular and tissue-based products (HCT/Ps) regulated as devices, the distinct identification code required in 21 CFR (c). In addition to specific device identification, information about the device is entered into the GUDID, which includes the device identifier, and each of the following items. Production identification is not required: If the device is direct marked, what the device identifier is, if it is different than the label of the device Previous device identifier if the labeled device is a new version or model The size of the device version or model The type of production identifiers on the label FDA premarket submission type, number and listing number(s) The Global Medical Device Nomenclature (GMDN) term FDA product code (procode) The number of individual devices in each package The version or model number of the device The device labeler (the person who causes a label to be put on a device or the label modified and the device introduced into commerce) 2

3 Why UDI is important When FDA published the proposed rule for UDI, it identified several objectives. During the course of preparing the final rule, the Food and Drug Administration Safety and Innovation Act (FDASIA) was passed, which required FDA to revisit the proposed UDI rule and make some adjustments. However, the objectives of the rule remained the same: 1. Reduce medical errors 2. Simplify the integration of device use information into data systems 3. Provide for more rapid identification of Medical Devices with adverse events 4. Provide for more rapid development of solutions to reported problems 5. Provide for more rapid, more efficient resolution of device recalls 6. Better focused and more effective FDA safety communication 7. Provide an easily-accessible source of definitive device identification information According to the notice of the final UDI rule, published in Federal Register 78 FR 58785, pp on Sept. 24, 2013, UDI will substantially reduce existing obstacles to the adequate identification of medical devices used in the United States. Medical errors will be reduced since it will be possible to rapidly and definitively identify a device and key attributes that affect its safe and effective use. This is because errors can result from misidentification of a device or confusion concerning its appropriate use. In addition, the identification system established under the UDI rule is expected to lead to more accurate reporting of adverse events. Once UDI is implemented, the party who is reporting an adverse event will be able to more accurately identify the device that is the subject of the report. Finally, FDA believes that UDI will allow FDA, health care providers, and industry to more gain insight into device issues by rapidly extracting information from the GUDID and adverse reports. This should help in understanding underlying device problems so they can be useful in corrective actions and in future device design. 3

4 Key dates in implementing the rule The table below outlines key compliance dates for implementing elements required in the UDI final rule which can be found in Table 3 of the final rule. NOTE: There is 3-year exception for finished devices that are already labeled and in inventory at the compliance date. Compliance Date Requirement The labels and packages of class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. 1 year after publication of the final rule (September 24, 2014) Dates on the labels of these devices must be formatted as required by 21 CFR Data for these devices must be submitted to the GUDID database. A 1-year extension of this compliance date may be requested under 21 CFR ; such a request must be submitted no later than June 23, Class III stand-alone software must provide its UDI. The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. 2 years after publication of the final rule (September 24, 2015) 3 years after publication of the final rule (September 24, 2016) Dates on the labels of these devices must be formatted as required. 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. Stand-alone software that is a life-supporting or life-sustaining device must provide its UDI. 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. 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. The labels and packages of class II medical devices must bear a UDI. Dates on the labels of these devices must be formatted as required. Class II stand-alone software must provide its UDI. Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database. 4

5 5 years after publication of the final rule (September 24, 2018) 7 years after publication of the final rule (September 24, 2020) 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. 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. Dates on the labels of all devices, including devices that have been excepted from UDI labeling requirements, must be formatted as required by the rule. 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. Class I stand-alone software must provide its UDI within the software itself. 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. Regulatory Strategy It is important for companies to develop a strategy early for compliance to the new UDI requirements. The strategy needs to include how to identify all product versions and models, what class they are in, what the current labeling scheme is, and perform a gap analysis on what needs to be in place for proper labeling in a timely manner under the rule. It is also necessary to determine the technology that the company will use for its barcoding, which FDA approved issuing agency it will employ, be prepared to set up the accounts that will be needed tor recording information in the GUDID, and how to get the proper resources for populating the GUDID. Companies will most likely need to identify a labeling software package that will meet the requirements of the rule for labeling, and know which resources they will need to design and implement new labels for products within the compliance date requirements. Some nuances to the rule include: Must employ human and machine readable identifiers Production identifiers are not required on Class I products GMP exempt Class I products are completely exempt from the UDI rule, however, ALL devices, including those that are exempt from the device identifiers, must employ the standardized date format now adopted by FDA: four-digit year followed by two-digit month followed by two-digit day. The day must always be included in the standardized date format. The month and year alone is not sufficient. 5

6 Single-use devices do not require the UDI on each individual device, but rather on the next higher level of packaging. Stand-alone software must have the UDI in the software so it can be identified, since software is often virtual. GUDID access is limited initially to Class III and PHS Act device labelers. Regulations and ensure that companies are in compliance with these changes. Other Conforming Amendments The UDI required a number of conforming amendments to other sections of the U.S. Medical Device Regulations. These sections are: Part 803 Medical Device Reporting Part 806 Reports of Corrections and Removals Part 810 Medical Device Recall Authority Companies should become familiar with the changes to these parts as they implement a UDI strategy. Furthermore, as part of the UDI implementation, FDA will rescind NDC/NHRIC numbers no later than year 5. However, a manufacturer may continue to use an FDA issued NHRIC labeler code if the labeler submits a request for continued use within year 1, or by Sept. 24, How can UL help? UL can assist companies to achieve compliance to the UDI rule by providing experienced resources to perform gap analyses, identify technology pathways, prepare project planning documents and assist in implementing the project plan. We can also assist in navigating the changes to the other sections of the Medical Device Regulations and ensure that companies are in compliance with these changes. Part 814 Premarket Approvals Part 820 Quality System Regulation Part 821 Medical Device Tracking Requirements Part 822 Postmarket Surveillance Author: Linda Chatwin Linda Chatwin, RAC is the North America Manager for UL s Medical Regulatory Advisory Services team. Ms. Chatwin has worked in the medical industry for over 20 years and most recently served in global regulatory affairs for a multi-national medical device manufacturer. She has extensive experience in global medical device regulatory affairs, legal compliance and documentation and now supports manufacturers with advisory services to support global regulatory approvals and post-market quality system remediation. This article is for general information purposes only and is not intended to convey legal or other professional advice. 6