Medical device manufacturers looking to distribute medical devices in the US are required to register their medical devices with the FDA. The registration process for medical devices differs based on the risk of the device. There are three classifications of medical devices: class I, class II, and class III. Based on the device’s classification, they are subject to different regulatory controls. Some devices are ready for distribution once the manufacturer lists them on the FDA’s website based on the regulatory controls. Some devices require a premarket notification to the FDA, and some devices require the FDA’s approval. Device classification and regulatory controls can be very device-specific.
Device Classification by Risk
Class I medical devices are the lowest risk device. Most devices are class II medical devices. And hazardous devices are class III medical devices. The best way to determine the class of a medical device is to use the FDA’s classification database and to search competitive devices. By understanding a similar device’s classification can inform what the classification should be on a new device. The device classification is a very important part of determining the registration requirements because the requirements are very different from a class I and class II device. If uncertain about a new device’s classification, the FDA allows manufacturers to have meetings to discuss. Periodically FDA may assess device classifications to ensure they are accurate. FDA may re-classify devices.
General, Special, and Premarket Controls
Once the device classification is established, then manufacturers can focus on what controls need to be implemented for their medical device. General controls are required for all medical devices.
- Must not be adulterated
- Must not be misbranded
- Device be registered under FDA’ device registration and listing
- The manufacturer must be registered under FDA’ establishment registration
- Must not be banned
- Must notify users of repairs, replacements, or refunds
- Must maintain records and reports on the device and device’s manufacturing
- Must comply with Good Manufacturing Practices (GMP)
Special controls are typically required only for Class II medical devices. However, the FDA can ask for these to be implemented for Class I or Class III medical devices. Typically special controls are device-specific requirements. Special controls include:
- Conformance with performance standards (if any)
- Post-market surveillance of the device
- Patient registrations for patient-specific products and implants
- Pre-market data requirements: typically testing to support a 510(k) application
If a device is a Class III device, then it is subject to FDA’s premarket approval. What this means is that manufacturers must submit safety and efficacy data regarding their devices to the FDA. The FDA will review all of the data and make a decision on if the FDA approves this product. The FDA can also request manufacturers to annually submit additional data, including sales data, recall information, and changes to maintain the product’s approval.
No matter the device’s classification or controls, DeviceLab is here to help you bring your product to market and meet FDA’s regulatory requirements. Contact us today to set up a consultation.