Obtaining Food and Drug Administration (FDA) authorization to market a new medical device in the United States can be time-consuming and challenging. An especially critical step during this process is determining the amount of data needed to demonstrate device safety and effectiveness. This article will explore the question, “How much data is needed to get FDA clearance?” analyzing the regulatory requirements for releasing medical devices and the factors that determine the amount of data required [1-5].
The FDA is responsible for ensuring the safety and effectiveness of medical devices marketed in the United States. The regulatory pathway is divided by the risk level of the device, nowadays, FDA classifies medical devices into three categories based on the potential risk to the patient:
- Class I (low risk);
- Class II (moderate risk);
- Class III (high risk);
Class I medical devices are those which are considered to pose the least amount of risk to patients. These devices are generally simple in design and aren’t intended to be used for invasive or life-sustaining purposes. Examples of Class I medical devices include:
- Non-medicated adhesive tapes
- Tongue depressors (and other simple medical instruments)
- Stethoscopes and other diagnostic instruments
- Simples diagnostic test kits (i.e, pregnancy tests)
Incontinence pads and other mobility aidsIt’s worth noting that while Class I devices are considered to pose the least amount of risk, they are still subject to FDA regulatory oversight to ensure their safety and effectiveness. Manufacturers of Class I devices are required to register with the FDA and comply with quality system regulations to ensure that their devices are manufactured and distributed in a safe and effective manner .
Moderate-risk medical devices (Class II) pose a higher risk than Class I devices. Class II devices typically require more regulatory controls than Class I devices, including premarket clearance by the FDA [1-5].
Class II devices are typically more invasive than Class I devices, for example:
- Medical imaging devices
- Powered wheelchairs and mobility devices
- Pharmacological delivery devices
- Surgical sutures and staples
- Ophthalmic devices
- Diagnostic devices
Manufacturers of Class II devices are required to submit a premarket notification (known as a 510(k)) to the FDA, which demonstrates that the device is substantially equivalent to a legally marketed device (predicate device) and does not raise any new questions of safety and effectiveness. The FDA review process for 510(k) clearance typically takes between three and six months, depending on the complexity of the device and the amount of data provided by the manufacturer.
Class III medical devices are considered to pose the greatest risk to patients and are subject to the highest level of regulatory controls. These devices usually sustain or support life, or present an unreasonable potential risk of illness or injury. Examples of Class III medical devices include:
- Implantable pacemakers and defibrillators
- Heart valves and other cardiovascular devices
- Artificial joints and other orthopedic implants
- Breast implants and other cosmetic implants
- Spinal cord stimulators and other neurostimulation devices
- Hemodialysis machines and other kidney dialysis equipment
- Automated External Defibrillators (AED)
- Mechanical ventilators and other respiratory support devices
The FDA requires manufacturers of Class III devices to submit a premarket approval (PMA) application that includes clinical data demonstrating the device’s safety and efficacy. The PMA process is more rigorous than the 510(k) clearance process and typically takes one to three years to complete, depending on the complexity of the device and the amount of data provided by the manufacturer. The clinical data required for a Class III device may include the results of clinical trials, animal studies, bench tests, and other types of data to demonstrate the safety and efficacy of the device. The FDA may also require post-marketing studies to monitor the device’s long-term safety and effectiveness after it has been cleared for use [1-5].
The complexity of the device is a critical factor. Continuous Glucose Monitors (CGms) for example, can be complex devices that include both hardware and software components. The FDA has issued guidance on the types of data that manufacturers should collect and submit to demonstrate the safety and effectiveness of CGMs. This guidance includes recommendations for clinical study design, including the use of appropriate study populations and endpoints, as well as recommendations for data analysis and presentation [1-5].
Finally, the existing scientific knowledge about technology is another factor that determines the amount of data required for FDA clearance. There is already a substantial body of scientific literature supporting the safety and effectiveness of CGMs for example, which may reduce the amount of clinical data required for FDA clearance. Nonetheless, as technology advances and new features are added to CGMs, additional data may be necessary to demonstrate their safety and effectiveness [1-5].
In summary, the amount of data required to obtain FDA clearance for a medical device depends on several factors, including the risk level of the device, the intended use of the device, the complexity of the device, and the existing scientific knowledge about the device. Manufacturers must carefully consider these factors when designing clinical studies and submitting applications for FDA clearance. By doing so, they can ensure that their devices are safe and effective for use in the United States, ultimately benefiting patients and improving public health.
1. Food and Drug Administration. (2019). Premarket Notification 510(k). Available from https://www.fda.gov/medical-devices/premarket-notification-510k
2. Food and Drug Administration. (2019). Premarket Approval (PMA). Available from https://www.fda.gov/medical-devices/premarket-approval-pma
3. Food and Drug Administration. (2021). Medical Device Classification Procedures. Available from https://www.fda.gov/medical-devices/overview-device-regulation/medical-device-classification-procedures
4. Food and Drug Administration. (2018). Clinical Considerations for Investigational Device Exemptions (IDEs) for Medical Devices. Available from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-considerations-investigational-device-exemptions-ides-medical-devices
5. Food and Drug Administration. (2018). Guidance for Industry: Clinical Studies of Continuous Glucose Monitoring (CGM) Systems Available from https://www.fda.gov/media/129346/download