What is a Class I Medical Device?
Key Takeaways
What is a Class I medical device - definition
Examples of Class I medical devices
Regulatory requirements
How to confirm your classification?
The FDA regulates all medical devices, assigning each a safety rating or “Class” (ranging from I to III) based on its level of risk, complexity, and degree of control to assure safety and effectiveness. Class I devices have the minimum requirements in comparison to Class II and Class III devices.
A Class I medical device is a device that the U.S. Food and Drug Administration has labeled in the lowest-risk category of medical device classification. These devices are generally designed with a minimal and straightforward approach and are typically non-invasive, posing minimal to no risk to patients or users. They are not intended to support or sustain life, nor are they of significant importance in preventing human health impairment.
Examples of Class I Medical Devices
Here are some general examples of Class I medical devices:
Bandages, gauze, and dressings
These are simple wound care items that are used everywhere.
Hospital beds
Although of large size, they can typically be Class I because they do not support life itself in invasive or critical ways.
Examination/surgical gloves and non‑electronic thermometers
Both items are of low risk when used according to specs.
Regulatory Requirements for Class I Devices
Although Class I medical devices are considered low-risk (for example, items such as bandages, stethoscopes, or manual surgical instruments), they are still subject to all regulatory requirements under the FDA medical device law. These laws guarantee that even simple devices are safe and effective for their intended use.
The least necessary requirements are known as General Controls, which are the baseline regulatory standards applied to all classes of medical devices (Class I, II, and III). They cover areas like registration, labeling, manufacturing practices, and record-keeping.
Some Class I devices are exempt from premarket notification (the 510(k) process)—meaning they don’t need FDA clearance before being marketed—or may be partially exempt from QSR requirements, depending on their specific regulation. However, “exempt” does not mean “unregulated.” These devices must still comply with General Controls, such as proper labeling, good manufacturing practices, and post-market monitoring.
The most significant regulatory requirements for Class I devices are:
Establishment Registration & Device Listing
Establishments (such as manufacturers, initial importers, or distributors), and in some cases other entities involved in the supply chain, are responsible for registering with the FDA and listing the specific devices they produce or market. The registration assures the FDA knows who is making and selling devices in the U.S., and which devices are being offered.
Labeling
Labels must contain clear, accurate, and complete information, including the intended use, warnings, instructions for use, and manufacturer details, to guarantee safe operation and prevent misuse. If a label is misleading, missing information, or incorrect, the device is considered “misbranded” under FDA law, which can lead to enforcement actions.
Quality System Regulation (QSR)
The QSR (also known as 21 CFR Part 820) defines the minimum manufacturing quality standards required by the FDA. It includes requirements for good manufacturing practices (GMP), record-keeping, design control, and process validation. For Class I devices, the level of oversight is lower than for higher-risk (Class II and III) devices, and some may be exempt from certain parts of QSR; however, basic controls—such as providing consistent production quality—still apply.
Complaint Handling and Post-market Surveillance
Even low-risk devices must have procedures to monitor their performance after they reach the market. These methods include setting up systems to receive, document, and investigate complaints, as well as to report adverse events to the FDA as necessary, which help detect any unexpected safety issues and maintain public confidence in the device’s safety over time.
Design & Development Considerations
Class I devices present a lower risk, but they still require good quality design and development standards. Part of the design process is to include the following considerations, which guarantee compliance, safety, usability, and manufacturability:
Clearly define Intended Use and Indications for Use
Determine early on what the device’s functionality is, who will operate it, where it will operate, and how it will function. These choices impact regulatory classification, risk, labeling, and the design of the user interface.
Risk Management
Even low-risk devices carry some risk (e.g., misuse, incompatibility of materials, contamination). Always conduct a risk assessment to identify potential hazards, evaluate their severity and likelihood, and develop effective mitigation strategies to address them.
Sterilization and Reprocessing
Use biocompatible, sterilizable, or cleanable materials where possible. Even for Class I devices, hygiene, robustness, and maintenance are indispensable, particularly when the device is intended for use in clinical settings or with patients.
Ergonomics and Human Factors
Consider how the users (clinicians, patients, caregivers) will physically interact with the device. Even a simple tool can be abused or cause strain, discomfort, or harm if not well-designed.
Manufacturing and Cost Efficiency
Most Class I medical devices have a simple design. However, "simple" does not mean "cheap sham." The design must be easy and profitable for manufacturers to produce. It must also align with a repeatable assembly, e.g., have minimal parts where possible and strict quality control.
Labeling & Instructions for Use (IFU)
Class I devices rely heavily on labeling for safe use. All devices must include clear, accurate, and readable instructions, along with graphic aids and regulatory compliance information for warnings and other relevant details.
Why Classification Matters
Knowing your medical device and how to classify it correctly has several key implications:
Regulatory Burden & Time-to-Market
Class I devices have fewer regulatory hurdles, a lower cost of compliance, and require less time to develop and manufacture. However, you mustn’t skip on quality or regulations. If you misclassify your device, you may experience unexpected delays or need to rework your documentation.
Documentation Requirements
While requirements are fewer, there are still obligations around labeling, record-keeping, and post-market surveillance., and the need to record complaints. Don’t underestimate these requirements, as they could lead to compliance issues.
Cost & Resource Planning
A Class I medical device typically involves lower regulatory complexity, which supports budgeting, production planning, and compliance activities. As a result, it can reduce overall development costs and minimize financial risk.
Liability & Exposure to Risk
The correct classification supports the safety of the device. If there is an issue, you will have the processes, traceability, and documentation in line to support your case.
Market Access & Strategy
To classify your device in foreign markets, you must be forward-thinking and prepare your documentation in advance. Entry into foreign markets may require special notifications, conformity assessments, or approval.
How to Confirm Your Device Classification
All medical device manufacturers must classify their devices early on. The classification helps with product development and streamlines the process. The easiest way to do this is to search the FDA's online classification database, where you can enter by device name, type, intended use, or product code. The query will direct you to the relevant regulation in the Code of Federal Regulations (CFR), Parts 862 through 892, which lists various types of medical devices.
In most cases, you can also determine your classification by checking your product against similar devices that are already legally marketed. Such "predicate devices" serve as a reference point for the intended application, level of hazard, and regulatory requirements. Always clearly outline your device's intended application and uses, as even slight differences in use, such as transitioning from a clinical to a home setting, can impact the classification and corresponding regulatory path.
Some Class I devices are exempt from premarket notification (510(k)) or parts of the Quality System Regulation. Depending on your device's classification number and the FDA's guidelines, you will need to assess whether your device is qualified for exemption or not. Suppose your device is either newly released or in an undefined state. In that case, you may submit a formal Section 513(g) request for a written classification determination directly from the FDA.
Next Steps After Classification
Once you have confirmed that your device is a Class I device, the next step is to organize your design and development steps in relation to the regulations and controls of your category.
Even though Class I devices are considered low-risk, they are still subject to general controls, including device registration, proper labeling, complaint reporting, and adherence to applicable sections of the Quality System Regulation. It helps if you can meet these requirements early on to establish designs that comply with regulatory requirements. It certainly saves time and money down the process.
Once classed, it’s time to refine the prototype. Even simple devices must be tested for usability. The feedback from the tests can identify issues with comfort, durability, or usability that may not be noticeable during the conceptual stage.
In the meantime, you can implement basic quality control procedures, such as documenting design inputs and outputs, establishing supplier controls, and implementing a process to handle complaints in accordance with regulations. This method is a reliable way to begin the design and manufacturing processes.
At this stage, you must gather and prepare all regulatory documentation, including product descriptions, use information, risk management summaries, and labeling requirements. If your device qualifies for exemption from 510(k) submission, you are still required to document the rationale and make sure that all other requirements are met. If it is not exempt, you need to prepare your premarket notification or other submissions in accordance.
After the launch, monitor product performance and respond to user feedback. Be vigilant for complaints or safety concerns. These post-market steps are required for compliance and continuous improvement even for Class I devices.
Suppose you plan to introduce new features or expand the indications for use of the device at some point in the future. In that case, you will have to reevaluate the classification of your device to determine whether changes require a different regulatory approach.
All medical device companies are looking to reduce time to market, mitigate risk, and meet compliance requirements. The best way to achieve efficiency, profitability, and speed is to partner with an experienced medical device development team that will design your medical device according to its classification category and prepare all necessary regulatory documentation and supporting materials.
HaA PD for Your Medical Device
HaA Product Development can help you identify the correct classification for your device and ensure you understand and navigate the regulations correctly. Contact us today and let us help you design a device that meets the needs of regulators and can be produced uniformly and at a competitive price!
