With more than 1,700 generic types of medical devices grouped into 16 medical specialties, Food and Drug Administration (FDA) approval for medical devices can be complicated and a bit overwhelming.
FDA medical device approval is also time consuming. Before starting the approval process, devices need to be developed, tested, studied and designed, processes that can take years. Once the medical product development and approval process starts, it can take three to 24 months for official approval.
Because the types of medical devices moving to market are so diverse, it would be impossible to give a blanket step-by-step guideline for FDA approval; however, everyone seeking FDA approval needs to know what classification of device they have, whether that class of device needs approval and what type of approval is necessary.
The FDA categorizes medical devices into three classes: Class I, Class II and Class III. Each class has specific regulatory and testing guidelines so it's critical to accurately determine a device's class before seeking FDA approval.
A Class I device is not intended to sustain or support human life and is therefore the least regulated of the three classes. Medical product development for a class I device might be for examination gloves or hand-held instruments.
A Class II device is designed to help patients but is at greater risk of causing a patient harm than a Class I device but not as high a risk as a Class III device. These devices may include wheelchairs or infusion pumps. They are subject to more controls and often require premarket notification. Some Class II devices are exempt from this requirement.
Class III devices are generally designed to sustain human life and therefore have a greater risk of harm to the human body. These devices include defibrillators and pacemakers. These devices are subject to premarket approval.
If you are struggling to classify your device, check out the FDA's Product Classification Database for medical device product development.
Unless your device is exempt from premarket notification (510k approval), you have to show the FDA that the device is substantially equivalent (SE) to a similar device already on the market. While this requirement doesn't apply to Class I devices, it applies to most Class II devices.
Within 90 days, generally, the FDA will decide whether the proposed Class II device is in fact SE. If the FDA approves the device, the person submitting the device is free to market it for use. An SE denial means the device cannot be marketed but may be resubmitted with new data.
The majority of Class III devices require premarket approval (PMA) meaning that the person or people seeking the approval must present scientific evidence proving the device is safe for use. This can come in the form of scientific data, non-clinical research or clinical investigations. Gathering this evidence can take years of study but it takes the FDA an average of 180 days to make decisions regarding PMA eligibility.
During that 180-day period, an FDA advisory committee will host a public meeting to discuss approval. If approval is denied, the person or company has 30 days to appeal to the FDA for reconsideration.
FDA medical device approvals were put in place to protect consumers by bringing safe, effective medical devices and resources to market. As you begin or continue your medical product development process, it's important to review FDA regulations to save time and money.
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