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Decoding Labeling Requirements: Understanding 21 CFR Part 801 for Medical Devices
The Code of Federal Regulations (CFR) is a comprehensive set of rules and regulations established by federal agencies in the United States. Title 21 of the CFR pertains to food and drugs, with Part 801 focusing specifically on the labeling requirements for medical devices. Ensuring proper labeling is critical for the safe and effective use of medical devices. This article will delve into the specifics of 21 CFR Part 801, providing a thorough understanding of its various sections, requirements, and implications for manufacturers and users.
What is 21 CFR Part 801?
21 CFR Part 801 outlines the regulations for labeling medical devices. These regulations are essential to ensure that users, including healthcare professionals and patients, have the necessary information to use medical devices safely and effectively. The labeling requirements cover various aspects such as the content and format of labels, the inclusion of warnings and instructions for use, and the identification of the manufacturer.
Who needs to be compliant with 21 CFR Part 801?
Compliance with 21 CFR Part 801 is mandatory for:
Manufacturers: Entities that produce and distribute medical devices intended for human use.
Packers and Labelers: Companies involved in the packaging and labeling of medical devices.
Importers and Distributors: Entities that import and distribute medical devices in the United States.
These parties must ensure that their medical device labeling meets the requirements set forth in 21 CFR Part 801 to avoid regulatory actions and ensure the safety of device users.
h2: What are the different parts of 21 CFR Part 801 and their requirements
21 CFR Part 801 is divided into several subparts, each detailing specific requirements for different aspects of medical device labeling. Here is an overview of each subpart:
Subpart A: General Labeling Provisions
Subpart A provides general information about labeling requirements, including definitions and general rules. Key sections include:
§ 801.1: Medical devices; name and place of business of manufacturer, packer or distributor.
This section outlines the requirement for the identification of the manufacturer, packer or distributor.
§ 801.3: Definitions
In this section, a list of definitions used in Part 801 is provided.
§ 801.4: Meaning of Intended Uses
This section stipulates that the intended use or objective intent needs to be clear. This is based on the submission file. The objective intent may be shown by labeling claims, advertising matter and oral or written statements.
§ 801.5: Adequate Directions for Use
Medical devices must include adequate directions for use to ensure that users can operate the device safely and effectively. These directions should be written in clear, contain all important information for the safe use of the device in an understandable language. If applicable, it needs to cover all necessary steps for the device's operation.
§ 801.6: Medical Devices; Misleading statements
This section defines misbranding and stipulates that a device is considered misbranded if its labeling is false or misleading in any particular way. Misleading statements can result in regulatory actions, including recalls and penalties.
§ 801.15: Medical Devices; Prominence of Required Label Statements; Use of Symbols in Labeling
It's important to ensure that all the information needed is clearly visible on the packaging. This means that there should be enough space. Symbols can help reduce the need for space, however, they should be applied as specified in this section. The main accepted language is English. For products that are only marketed in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used.
§ 801.16 Medical devices; Spanish-language version of certain required statements.
As already described in the previous sections, for specific Spanish speaking regions, Spanish can be used for labeling.
§ 801.18 Format of dates provided on a medical device label.
In general, the representation of a date is YYYY-MM-DD. Exceptions are described in this section.
Subpart B—Labeling Requirements for Unique Device Identification
Subpart B focuses on the specific requirements for unique device identification, which is a critical aspect of modern medical device regulation. Key sections include:
§ 801.20: Labeling to Bear a Unique Device Identifier
This section mandates that each medical device, unless exempted, must have a UDI on its label and packaging. The UDI must be in both human-readable and machine-readable formats, such as barcodes or RFID and in line with 21 CFR Part 830.
§ 801.30: General Exceptions from the Requirement for the Label of a Device to Bear a Unique Device Identifier
Certain devices are exempt from UDI requirements. This section outlines the categories of devices that are exempt, such as custom devices and investigational devices.
§ 801.35: Voluntary Labeling of a Device with a Unique Device Identifier
While some devices are exempt from mandatory UDI labeling, manufacturers may voluntarily include a UDI. This section provides guidelines for such voluntary labeling.
§ 801.40 Form of a unique device identifier
Every Unique Device Identifier needs to be compliant to the requirements of Part 830.20.
§ 801.45 Devices that must be directly marked with a unique device identifier.
In general it is required that devices that must bear a UDI on their label also need to have a permanent marking with the UDI on the device itself IF the device is intended to be used more than once and intended to be reprocessed before each use. This part describes those requirements and exceptions.
§ 801.50 Labeling requirements for stand-alone software
Stand-alone software, doesn't necessarily have a packaging. Therefore the UDI should be visible in a dedicated statement.
§ 801.55 Request for an exception from or alternative to a unique device identifier requirement.
In some cases a request for an exception regarding the UDI can be submitted. This part explains how such exception request should be filed.
§ 801.57 Discontinuation of legacy FDA identification numbers assigned to devices
As soon as a UDI is required for a device, the NHRIC or NDC number should no longer be provided. This is further detailed in this section.
Subpart C—Labeling Requirements for Over-the-Counter Devices
§ 801.60 Principal display panel.
The term principal display panel, as it applies to over-the-counter devices in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale.
§ 801.61 Statement of identity.
The statement of identity should be visible on the principal display panel. This statement includes the common name and an accurate statement of the principal intended actions of the device.
§ 801.62 Declaration of net quantity of contents.
The net quantity of contents must be visible on the label. This can be expressed in terms of weight, measure, numerical count or a combination.
§ 801.63 Medical devices; warning statements for devices containing or manufactured with chlorofluorocarbons and other class I ozone-depleting substances.
All over-the-counter devices containing or manufactured with chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or any other class I substance designated by the Environmental Protection Agency (EPA) shall carry specific warnings stated in this section.
Subpart D—Exemptions From Adequate Directions for Use
§ 801.109 Prescription devices
In case devices can only be sold with prescription, specific requirements apply.
§ 801.110 Retail exemption for prescription devices.
Devices that fall under the previous paragraph can have specific labels.
§ 801.116 Medical devices having commonly known directions.
Devices that are known to the ordinary individual, are exempt from adequate directions.
§ 801.119 In vitro diagnostic products.
IVDs need to comply with Subpart B and §809.10.
§ 801.122 Medical devices for processing, repacking, or manufacturing.
If devices are intended for processing, repackaging or use in the manufacture of a drug or another device, this needs to be mentioned specifically on the label.
§ 801.125 Medical devices for use in teaching, law enforcement, research, and analysis.
There are specific exemptions for devices used in teaching law enforcement, research and analysis
§ 801.127 Medical devices; expiration of exemptions.
Exemptions expire as soon as the device is shipped or delivered to a person which makes it fall outside of the scope of the exemption or until the device is to be used outside of the scope of the exemption.
§ 801.128 Exceptions or alternatives to labeling requirements for medical devices held by the Strategic National Stockpile
In order to have these exceptions granted, a request needs to be submitted to the Center Director.
Subpart E—Other Exemptions
§ 801.150 Medical devices; processing, labeling, or repacking
A shipment or other delivery of a device which is, in accordance with the practice of the trade, to be processed, labeled, or repacked, in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from compliance with the labeling and packaging requirements. There are several requirements for this exemption which are described in this section.
Subpart H—Special Requirements for Specific Devices
Under this subpart there are specific labeling requirements described for certain devices:
§ 801.405 Labeling of articles intended for lay use in the repairing and/or refitting of dentures
§ 801.410 Use of impact-resistant lenses in eyeglasses and sunglasses
§ 801.415 Maximum acceptable level of ozone
§ 801.417 Chlorofluorocarbon propellants
§ 801.422 Prescription hearing aid labeling
§ 801.430 User labeling for menstrual tampons
§ 801.433 Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances
§ 801.435 User labeling for latex condoms
§ 801.437 User labeling for devices that contain natural rubber
Documenting 21 CFR Part 801 compliance
Labeling and instructions for use are part of the design of your device. Ensuring that the labeling is in line with the intended use, the risk management file and the specifications of your device is the key to having this part of your device documentation approved. This is true not only for the first time you submit a file for approval but as well for subsequent changes to the device. Therefore it's critical to have adequate traceability between your design aspects. You, as a manufacturer, need to make sure that with every change it is clear whether or not the label and/or instructions for use need to be updated.
MatrixALM is a software platform that is made to make requirements management, risk managements and traceability within the design more efficient. It allows manufacturers to link all design aspects together and facilitates detecting gaps. The documentation that is linked to the design of your device can be extracted at any time for communication with regulatory authorities.
21 CFR Part 801 and Part 820 and Part 803
As a medical device manufacturer, you have to ensure that you comply with all relevant standards and parts of the legislation. 21 CFR Part 820 describes the requirements for your Quality Management System. This comprises many different procedures. One (or more) of them is about document control. This document control procedures also includes the control of the labeling and instructions for use described in 21 CFR Part 801. Furthermore, as part of the Quality Management System, change control should be embedded in a procedure. As mentioned before, it's critical to verify if changes have an effect on the labelling. Changes can come from internal decisions, but as well from Post Market Surveillance information. Part of this information exists of complaints and adverse events. Some of those adverse events will have to be reported as per 21 CFR Part 803.
The end goal of regulators is to ensure that safe and performant devices are being brought to the market. So it makes sense that all parts of the legislation are interlinked to ultimately achieve this goal.
Top 5 suggestions for 21 CFR Part 801 compliance
In summary of this post, we'll list our 5 key take aways when it comes to 21 CFR Part 801:
Define the intended use of your device clearly. It's the basis for all further requirements, including the labeling of your device
Examine if there are specific requirements for your device
Examine if there are any exceptions or exemptions applicable to your device
Integrate the control and design of your labeling and instructions for use in the design of your device to ensure it's fully part of the change control procedure and interlinked with all other design aspects of your device
Look for a tool such as MatrixALM to help you with the traceability in design to keep the overview
Matrix Requirements is the leading platform in design and quality control for SxMD (Software as/in Medical Devices) manufacturers. We offer an easy-to-use, all-in-one, flexible software solution to 5,000 users around the world that streamlines requirements management and quality compliance with full traceability and control.
Our 200+ clients, medtech leaders such as Medtronic, GE Healthcare, Stryker, Roche Diagnostics, and B.Braun, as well as startups and scale-ups such as Proscia, Element Biosciences, Clue, MindMaze and Diabeloop, are saving time in documenting product development and quality processes with our intuitive platform.