So, you have a medical device and want to market it, but you’re not sure how to do it legally. This process can be very involved, but not impossible. So long as you jump through the right hoops, in most cases you can safely and compliantly market your product.
What is Your Device Class?
The first step in bringing your device to market is to determine which Class of device it falls into. The FDA has established a classification system for medical devices based on the level of risk to a user that a particular device carries with it. This risk applies whether the device malfunctioned or worked exactly as planned. Every device falls into either Class I, Class II or Class III. And each of these classes requires different levels of regulatory scrutiny and compliance to ensure safety and effectiveness.
Class I medical devices are considered by the FDA to be low to moderate risk products. They include things such as bandages, toothbrushes, and tongue depressors. The likelihood of one of these doing any real harm – or at least significant harm – is very low. Therefore, most Class I devices do not need a Premarket Notification, or 510K. This is an FDA form and process that simply notifies the FDA that you are going to market a particular device. However, Class I devices are still subject to what the FDA terms General Controls. General controls are regulatory standards that all device companies must comply with in order to market their products in the U.S. They include requirements such as manufacturing standards, packaging and labelling, adverse event reporting, etc. General controls apply to all medical devices, unless they qualify as exempt under the federal Food, Drug, and Cosmetic Act. For example, toothbrushes are exempt from classification in any of the three Classes.
Class II medical devices usually require a 510K clearance, where the company must prove the device is substantially similar to a preexisting device. However, this is not always required. For Class II devices, the FDA requires both general controls as well as Special Controls for manufacturing and sale. Special controls are regulatory requirements that provide a reasonable assurance of safety and effectiveness for these riskier devices. Special controls are usually device-specific and include things such as performance standards, post-market surveillance, patient registries, special labeling requirements, and premarket data requirements.
Class III devices are a different animal altogether. Devices are considered Class III if they:
- are used to support or sustain human life;
- prevent impairment of human health; or
- may present a potential unreasonable risk of illness or injury for which general controls and special controls are insufficient to provide reasonable assurance of the safety and effectiveness of a device; or
- do not have sufficient information to determine a proper level of risk.
Class III devices include things such as pacemakers, breast implants, and defibrillators. They almost always require Premarket Approval (PMA) from the FDA, which involves much more than FDA notification or clearance. Premarket approval can be a long and involved process, but it is not meant to deter you from bringing a beneficial device to market.
Once you have determined which class your device fits into, you are ready to jump through the FDA hoops to bring it to market.
Let us help guide you in this involved and sometimes complicated process.