Regulations related to medical devices fall under the purview of the FDA, and it should go without saying that there are number of requirements related specifically to medical device labeling that must be met in order to remain compliant in the United States. Adhering to labeling requirements is important for human health and safety, medical device quality, and regulatory compliance.
Labeling medical devices is important because labels convey information about the device, part, product. This information could be a warning/hazard, instructions and guidance, or simply product identification. Regardless, a label is a vital component of conveying information to patients, medical professionals, technicians, logistics personnel, etc.
GMP Labeling Inc. is the premier provider of quality control, identification, and compliance labels for medical device companies. In this article we will summarize the key medical device labeling requirements as of 2023. This article is informational and is not exhaustive nor intended to be used as legal or regulatory guidance for your application.
What is a label?
Let's start at the simplest concept (that is, of course, defined by the FDA) and define what constitutes a label. Per Part 801 of 21 CFR Section 201(k) of the Federal Food, Drug, and Cosmetic Act (FFD&C Act), a label is:
a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under the authority of this Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.
Essentially, a label can be written or printed words (or graphic) that is located on the immediate container of an article AND is appears on any outside container or wrapper.
What are the Labeling Requirements in the United States?
There are two laws related to the labeling of medical devices in the United States: The Fair Packaging and Labeling Act (FPLA) and the Federal Food, Drug, and Cosmetic Act (FFD&C Act). From FPLA and FFD&C Act, there are a variety of sections and requirements codified as Federal Regulations under Title 21 of the US Code of Federal Regulations (CFR). Namely:
- 21 CFR Part 810 - General Device Labeling
- 21 CFR Part 809 - In Vitro Diagnostic Products (IVD)
- 21 CFR Part 812 - Investigational Device Exemptions
- 21 CFR Part 820 - Good Manufacturing Practices (GMPs)
- 21 CFR Part 830 - Unique Device Identification (UDI)
Below is a high level summary of each provision and Code of Federal Regulation as it relates to labeling.
21 CFR Part 810 - General Device Labeling
Medical Device labels must be an FDA-compliant label and should include:
- Manufacturer Name and Address
- Intended use of the device
- Adequate instructions to safely operate the device
- No false or misleading statements
- Displayed prominently in an appropriate location
- Unique Device Identifier (UDI)
In addition, 21 CFR Part 810 covers the use of symbols and graphics on medical device labels.
21 CFR Part 809 - In Vitro Diagnostic Products (IVD)
In Vitro Diagnostic products are used to gather samples, test samples and diagnose diseases or conditions. IVD products include instruments, systems, chemicals (such as reagents) that are used for collection and examination of biological specimens. Part 809.10 covers the requirements for labeling IVD products in order to remain compliant with the FDA.
21 CFR Part 812 - Investigational Device Exemptions
The FDA allows certain medical device products to be used for investigational research or clinical studies. These devices are exempt from certain requirements in order to be used for research purposes. However, it is important that the Investigational Device be labeled appropriately with a label that states: "CAUTION - Investigational device. Limited by United States law to investigational use." GMP Labeling carries a stock label that meets this requirement.
21 CFR Part 820 - Good Manufacturing Practices (GMPs)
The namesake of our company, Good Manufacturing Practices are FDA regulations related to the manufacturing of medical device, pharmaceuticals, foods, etc. GMPs allow a manufacturer to consistently and repeatedly produce high quality, safe, and uniform products. Generally, Medical device labeling requirements related to GMP are covered in Subpart 820.120, but some additional labeling requirements include:
- Subpart 820.61 - Measurement Equipment - "calibration date, the calibrator, and the next calibration date shall be displayed"
- Subpart 820.80 - Control of Components - "identification... shall be easily viewable. All obsolete, rejected.... components shall be clearly identified."
- Subpart 820.160 - Finished Device Inspection - "shall be held... or otherwise adequately controlled until released"
- Subpart 820.181 - Device Master Record - "packaging and labeling specifications."
GMPs and Subpart 820.120 require medical device manufacturers to create and maintain a labeling process, procedures to control labeling activities, storage, operations, label inspections, and control numbers.
21 CFR Part 830 - Unique Device Identification (UDI)
And finally, in order to comply with Federal Regulations, medical devices must be assigned and labeled with a Unique Device Identification number. UDI's are issued by a system operated by the FDA or an accredited agency and must meet the requirements set forth by Subpart 801.20 and Part 830.
How Can GMP Labeling Inc. Help?
Since 1987, we have been providing quality control and compliance labels to medical device manufacturers. We have many stock Regulatory Compliance Labels available and can help produce a custom label for your operation.
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