Overview of 21 CFR Part 801
21 CFR Part 801 outlines FDA labeling requirements for medical devices sold in the U.S. These regulations ensure that all devices have clear, accurate instructions, warnings, and identification information to protect user safety and promote proper use.
This regulation applies to all medical devices, covering general labeling requirements and specific content such as usage instructions and warnings. By following 21 CFR Part 801, manufacturers help prevent misuse and maintain compliance with federal law.
GMP Labeling offers compliant labeling solutions to help you meet these requirements effectively.
Subpart A—General Labeling Provisions
Subpart A covers the foundational rules for medical device labeling. It makes sure labels contain essential information, are clear, and are placed prominently. This applies to all medical devices and sets the groundwork for specific requirements in later sections.
What Information Should Be on the Label?
Medical device labels must include the device name, intended use, and manufacturer or distributor’s information to confirm the device can be properly identified and traced by healthcare providers and users.
Inadequate or missing information can result in regulatory non-compliance, leading to product recalls or delays in market access. Ensuring every detail is properly displayed is crucial to smooth regulatory approvals.
What Does 'Adequate Directions for Use' Mean?
'Adequate directions for use' refers to providing clear instructions for safe and effective use, including warnings and handling information, so users can interact with the device correctly.
Labeling Requirements for Unique Device Identification (UDI) (Subpart B)
Subpart B establishes the framework for including a Unique Device Identifier (UDI) on medical device labels. The UDI system enhances traceability and safety by making sure devices can be identified throughout their distribution and use. Some devices are exempt from this requirement based on their classification.
What Is a Unique Device Identifier (UDI)?
A Unique Device Identifier (UDI) is a distinct code assigned to medical devices for identification and tracking in the supply chain. It consists of a Device Identifier (DI) for the model and a Production Identifier (PI) for specific production details like lot or serial numbers. UDIs are often incorporated into barcode labels to streamline scanning and data capture throughout distribution and usage.
Which Devices Are Exempt from UDI Requirements?
Devices exempt from UDI requirements include those manufactured and used in a single healthcare facility, some Class I devices, custom devices, and products intended for export or investigational use. While these devices may be exempt from UDI, they must still be properly labeled for identification. Products intended for export must carry appropriate labels indicating their export-only status, and devices for investigational use require clear cautionary labeling to ensure proper handling and compliance with regulatory guidelines.
Which Devices Must Be Marked with a UDI?
Most Class II and Class III medical devices, as well as many Class I devices, must carry a UDI. The UDI must appear on the label and, for some devices, on the device itself to guarantee proper identification throughout its lifecycle.
Labeling Requirements for Over-the-Counter (OTC) Devices (Subpart C)
Subpart C sets the guidelines for labeling Over-the-Counter (OTC) devices. Labels must provide clear, accessible information for consumers to use these devices safely without medical supervision. This includes proper identification and content declarations.
Display Panel and Product Identity
OTC device labels must feature a display panel that clearly shows the product's common or usual name, making it easy for consumers to identify and understand the device.
Declaring the Quantity of Contents
OTC device labels must declare the quantity of contents, whether by weight, volume, or count, to ensure transparency and help consumers make informed purchasing decisions.
Exemptions From Adequate Directions for Use (Subpart D)
Subpart D addresses exemptions for certain devices that do not require "adequate directions for use" on their labels. These exemptions typically apply to devices that need professional oversight or have specialized uses.
Prescription Devices and Retail Exemptions
Prescription devices are exempt because they are used under healthcare provider supervision. Retail exemptions may apply when devices are sold through professional channels, relying on provider guidance.
Commonly Known Devices and IVDs
Devices widely recognized by the public or used in controlled environments, like In Vitro Diagnostics (IVDs), may also be exempt from detailed labeling.
Special Exemptions for Manufacturing, Research, and Education
Devices used specifically for manufacturing, research, or education are exempt from standard labeling requirements because they are typically handled by trained professionals.
Expiration of Exemptions and Alternatives
Exemptions may expire if a device's use or classification changes. In such cases, manufacturers must comply with standard labeling rules or seek alternative methods while meeting safety standards.
Subpart E—Other Exemptions
Subpart E covers additional exemptions for certain medical devices in unique scenarios where standard labeling might not be necessary, such as devices managed by professionals or used in limited contexts.
Labeling Exemptions for Bulk or Repacked Devices
Devices sold in bulk or repackaged for further distribution may be exempt from standard labeling, as they will be relabeled by distributors or end users. However, identification and traceability must still be maintained.
Subpart H—Special Requirements for Specific Devices
Subpart H outlines unique labeling requirements for specific device categories to meet tailored safety and regulatory standards beyond general guidelines.
Hearing Aids and Similar Devices
Hearing aids and similar devices require detailed labeling with clear instructions and safety information to ensure proper use and maintenance, given their role in daily life.
Denture Repair Kits and Eyewear
Denture repair kits and non-prescription eyewear must include instructions for safe use, along with necessary warnings, particularly for products involving direct consumer applications.
Products Using Ozone or Chlorofluorocarbons (CFCs)
Devices using ozone or CFCs must include labels indicating their presence, with warnings about environmental impact and safety instructions for handling.
Tampons, Condoms, and Latex Products
Tampons, condoms, and latex products must have labels addressing health and safety, including usage instructions and warnings about potential allergic reactions, such as latex sensitivity.
GMP Labeling Helps Ensure Compliance and Delivers Custom Labeling Solutions
GMP Labeling specializes in providing custom labeling solutions that meet all regulatory requirements, including those outlined in 21 CFR Part 801. Our expertise ensures your medical device labels are compliant with FDA regulations, from UDI requirements to special exemptions. With years of experience in the industry, we help you navigate complex labeling standards, offering high-quality, durable labels tailored to your specific needs. Reach out to a specialist today to learn how we can assist with your compliance and labeling needs.
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