Overview of FDA Classification for Medical Devices and IVDs
The FDA classifies medical devices into three risk-based categories: Class I, Class II, and Class III. These categories depend on the level of regulatory control required to ensure safety and effectiveness. Here’s a quick breakdown:
- Class I devices are subject to general controls and are often exempt from pre-market submissions.
- Class II devices require both general and special controls and typically need a 510(k) pre-market notification, unless specifically exempt.
- Class III devices, which pose the highest risk, generally require Pre-market Approval (PMA) unless they qualify for a 510(k) based on historical use.
Understanding Substantial Equivalence and Its Role in FDA Classification
Substantial equivalence is a fundamental concept for FDA device classification. It’s a technical benchmark that informs how the FDA views your device, the controls that apply, and how quickly you can bring it to market.
To establish substantial equivalence, you must demonstrate that your device is at least as safe and effective as a predicate device already on the US market. The comparison is based on three main factors:
- Intended use and indications for use
- Technological characteristics (e.g., materials, design, mode of action, energy source)
- Performance data (from bench, animal, and clinical testing)
If your device is found substantially equivalent, it will carry the same risk classification as the predicate and may be eligible for 510(k) clearance. If not, your device may be classified as a new type, requiring a De Novo request to establish a new classification regulation. For high-risk devices, a Pre-market Approval (PMA) submission might be necessary.
Defining Intended Use vs. Indications for Use to Determine Classification
The intended use and indications for use statements are crucial to FDA device classification and premarket submissions. Here’s how the FDA evaluates these terms:
- Intended Use: This describes the general purpose of the device or IVD, including what it does, who it's for, and how it's used.
- Indications for Use: These are more specific and define the disease or condition the device diagnoses, treats, prevents, or monitors. They also include the target population and use environment (e.g., home use vs. professional use, etc.).
Even small changes to these statements, like expanding the patient population or switching from professional-only to home-use, can impact the device's classification. This may affect the predicate options for establishing substantial equivalence (SE), the product code, and risk classification, as well as the submission requirements.
How to Classify Your Medical Device Under US FDA
FDA classification has four key steps:
- Define your device’s Intended Use and Indications for Use
- Identify the relevant device regulation in CFR Title 21 - Food and Drugs: Parts 862-892.
- Search the FDA Product Classification Database to identify possible product codes.
- Review substantially equivalent predicate devices in the FDA 510(k) Database based on similar intended use and characteristics.
The FDA assigns a unique product code to each type of medical device or IVD. These three-letter codes group devices with similar intended use and technological characteristics under a common regulation number found in CFR Title 21: Parts 862-892. The product codes and regulation numbers determine the classification tier (i.e., Class I, II, or III).
The FDA Product Classification Database is the primary tool for identifying the correct product code, regulation citation, device class, and applicable submission type (e.g., 510(k), PMA, De Novo, exempt). Each entry also provides valuable insights, such as guidance documents, recognized standards, and historical decisions, to help you understand FDA expectations for a device type.
