Medical Device Regulations

Medical Device Regulations | UDI Compliance Software

The words “UDI compliance” can often be broken into two separate conversations or paths therefore, the mere use of the words UDI compliance usually refers to a subset of the complete UDI compliance endeavor. It usually takes a minute or two of conversation or further reading to understand what a person is referring to when they use the term UDI compliance. The complete UDI compliance endeavor can range from the inclusion of GS1, HIBCC or ICCBBA compliant barcodes and other required content within a label or direct mark all the way to the management and submission of regulatory data (mainly attribute information) to appropriate regulatory bodies based upon the intended distribution of products. Most medical device manufacturers and or labelers have correspondingly broken their label production and their regulatory data management and submission functions across two different departments or divisions. Although labeling and submissions are only a part of complying with Medical Device Regulations overall, they can be very important and challenging pursuits.

Medical device companies have been saying, UDI labeling is being handled by the ABC department (usually the labeling or packaging department) and UDI is being handled by the XYZ department (usually regulatory or product management). These same manufacturers are now coming to realize that in many cases, much of the same data is being used across separate yet highly related pursuits. The difficulty of ensuring clean and consistent sets of data for both of these paths is coming to light as content errors within the U.S. FDA GUDID are continuously being reported. Medical device companies are also becoming aware that their trading partners are requiring access to information about medical devices via data pools. But other significant realizations are taking place.

Up until recently, the term”UDI” referred to the U.S. FDA rule. Fortunately, as other regulatory bodies (representing countries or groups of countries, etc.) develop their approach to achieve similar goals to the U.S. FDA version of UDI, there are more similarities in approaches than differences across them. As other regulatory bodies institute their, “UDI” or, “UDI like” requirements, the complexity of managing localization within a global environment increases exponentially. Many medical device manufacturers have relied upon Microsoft Excel® as a means of collecting their regulatory data for their initial submissions to the GUDID. They are now realizing that this was a stop gap measure and on-going update and maintenance responsibility for submitted data when combined with the need to re-use data for submission to other regulatory bodies means that Excel® will not continue to carry them forward and they need purpose built UDI compliance software. The complexity of managing country or regulatory body data approval across multiple departments or with multiple contract manufacturers, elucidates this fact.

Innovatum’s ROBAR product family (ROBAR Labeling and ROBAR MDM and ROBAR COM) are UDI compliance software products that equip you with an ability to efficiently manage all of the challenges listed above. Most importantly, with Innovatum’s product line, you can be equipped with one integrated UDI solution set that comes from one company. Most significantly, Innovatum has a stellar track record and wealth of experience in assisting medical device manufacturers to reach their Medical Device Regulations compliance goals (including UDI) in the most efficient and problem free way possible.

 

Unique Device Identification Summary

UDI is a United States FDA regulation that requires designated medical devices sold in the United States to adhere to certain standards of labeling. UDI also requires the recording of device attributes in a database called the Global Unique Device Identification Database (GUDID).

 

Impact To Manufacturers

The impact of UDI on medical device manufacturers will vary dramatically depending on the flexibility of their existing systems and the number of items which are subject to registration.

There are several areas which will require adoption, enhancement and capability.  These can be divided into:

  1. Selecting an FDA-accredited Issuing Agency
    1. Prospective candidates include,
      • GS1
      • HIBCC
      • ICCBBA
      • Others
    2. Identifying a Database(s) to store UDI data
    3. Assigning unique codes to all items -Maintaining, tracking, and reporting.
    4. Labeling functionality
      1. Linear (1-D Barcodes) and/or
      2. 2-D Barcodes and/or
      3. RFID and other AIDC technologies
    5. Communication with FDA Database GUDID – Non Proprietary data, device identification data only (no production-level data)


UDI Conventions

Medical Device Classes Equate To Patient Risk
Class III and Class II (CFR Title 21 part 860)
Device Identifier (DI) Plus, (mandatory, if used by the manufacturer for identification)

  • Production Identifier (PI)
    • Lot/Batch
    • Exp Date
    • Prod Date
    • Serial Number

Class I (CFR Title 21 part 860)

  • Device Identifier (DI), and optionally
  • Production Identifier (PI)
    • Lot/Batch
    • Prod Date
    • Others

What Medical Devices Need to be Marked

A wide range of medical products can be marked, such as the following examples:

  • Traditional hospital based devices (beds, ventilators, monitors, infusion pumps)
  • Implants
  • Patient/home use devices (glucometers)
  • Disposables, accessories (glucose test strips, catheters)
  • In vitro diagnostic devices (IVDs) – both clinical lab and Point of Care (POC).
  • Health Information Technology (HIT)
  • Convenience kits, combination products
  • Those used in alternative sites – e.g., homecare, dental

Benefits of UDI

  • Allows more accurate reporting, review and analysis of adverse event reports for problem device identification and remediation.
  • Reduces medical errors by enabling rapid and precise identification of a device and important characteristic information.
  • Enhances FDA analysis of devices on the market via a standard and clear way to document device use. A more robust postmarket surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
  • Provides standardized identifiers allowing manufacturers, distributors and providers to better manage medical device recalls.
  • Creates a baseline for a global secure distribution chain, address counterfeiting, diversion of product, and prepares for medical emergencies logistics.
  • Leads to the development of a medical device identification system that is recognized around the world.

UDI Compliance Dates for Class I and Unclassified Devices

In order to extend the compliance dates for lower-risk medical devices, the FDA plans to issue a guidance document to provide an enforcement discretion policy for labeling, GUDID data submission, standard date formatting, and direct mark requirements for class I and unclassified devices as indicated in Figure 1 below. This enforcement discretion policy would not apply to class I or unclassified implantable, life-supporting or life-sustaining devices1 because labelers of these devices must already be in compliance with UDI requirements.

Type of Device Label (21 CFR 801.20), GUDID Submission (21 CFR Part 830, subpart E), and Standard Date Format (21 CFR 801.18) Requirements Direct Mark (21 CFR 801.45) Requirements
Class 1 devices2 September 24, 2020 September 24, 2022
Unclassified devices September 24, 2020 September 24, 2022

Figure 1

1 For implantable, life-supporting or life-sustaining devices of all classes, the compliance date for all UDI requirements and the standard date format requirement (21 CFR 801.18) was September 24, 2015.
2 Class I CGMP-exempt devices are excepted from UDI requirements. 21 CFR 801.30(a)(2)

For more information, see “Letter to Device Labelers on UDI Compliance Dates for Class I and Unclassified Devices – June 2, 2017”.

Compliance Dates Established by FDA in Conjunction with UDI Final Rule

Compliance Date Requirement
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.
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.

Implantable, Life-Saving, and Life-Sustaining Devices

List of medical devices the FDA classifies as implantable, life-saving, and life-sustaining for purposes of section 614 of FDASIA amending section 519(f) of the FDC Act, March 2015 (PDF – 84KB). Labelers may refer to this link as a guide, but it is not a definitive list of implantable, life-saving, and life-sustaining devices subject to the September 24, 2015 UDI compliance date.

We recommend that labelers search the CDRH Product Classification database for the most current information on FDA product codes to determine if the devices within an FDA product code are considered implantable, life-saving (life-sustaining), or life-supporting.

The labeler should also evaluate the characteristics of the device and look to the device’s intended use to determine whether a particular device is life-saving, life-sustaining or implantable and follow the appropriate compliance dates and rules. For the purposes of determining the applicability of UDI requirements, refer to 21 CFR 860.3(e) for the definition of life-supporting or life-sustaining device, and refer to 21 CFR 801.3 for the definition of implantable device.

There are also a number of general exceptions from the requirement for the label of a medical device to bear a UDI.

For more information about UDI Exceptions, Alternatives, and Time Extensions, please see the UDI Exceptions, Alternatives, and Time Extensions webpage.