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. Trying to boil down the entire process into one article is nearly impossible. But here are the basics.
1. Decide Which Class Your Device Falls Into
The first step in bringing your device to market is to determine the class it belongs in. 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 has malfunctioned or works 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. See our article Marketing A Medical Device:Which Class Does It Fall Into for more detail.
In short, Class I devices – such as a bandage or a tongue depressor – pose little risk to the end user. Class II devices – such as syringes or tampons – pose greater risk but not usually life threatening. The FDA considers Class III devices as those that support life, are implanted, or could cause serious harm, such as breast implants or pacemakers. These involve very stringent regulatory requirements for approval and marketing.
Class I Devices
If your device qualifies as a Class I, you probably don’t need a premarket notification called a 510K. This is a form/process for notifying the FDA that you intend to market a device in the U.S. However, there are certain Class I devices the FDA considers risky enough for further scrutiny. Those on this list – called the Reserved List – require a 510K notification process. Class I devices also require General Controls. These are regulatory standards for manufacturing, packaging, labeling, etc. that are required for sale in the U.S.
Class II Devices
If your device falls into the Class II category, it means it has a higher risk of doing harm to a user. This class includes things such as heart monitors, dental implants, and wheelchairs. Class II devices require not only general controls but also heightened standards for manufacturing and monitoring called Special Controls. Most Class II devices require a 510K filing, but not all. If your device was legally marketed before May 28, 1976, it is considered “exempted,” or “grandfathered in, and a 510K is not required.
If your device is not on the exempted list, you need to look to see if your device is close enough in design and purpose to another existing device, called a Predicate Device. Since a predicate device has already gone through all the regular FDA clearances, you are not required to reinvent the wheel, so to speak. The FDA will be satisfied that your similar device is safe enough to simply file a 510K.
If there is no predicate device similar to yours, you will need to file for a De Novo device. This just means that you are marketing a brand new type of device, and the FDA wants the chance to see what class it falls into. De Novo is just a Latin word meaning “anew” or “from the beginning.” The De Novo process is not as complicated as it may sound, but you should seek guidance on how to do the filing properly. Once the FDA determines the proper classification of your device, you can start marketing it.
Class III Devices
Class III devices are very different from the other two classes. A device is considered Class III if:
- It is used to support or sustain human life;
- It prevents impairment of human health;
- It 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
- It does not have sufficient information to determine a proper level of risk.
Class III devices 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. The only time a Class III device does not require a PMA is when it is substantially similar to a predicate device manufactured prior to 1976. If this is the case, you may file a 510K only. If not, you must follow the PMA process.
2. Find a Manufacturer
As you begin the regulatory filing process, you will need to find a suitable manufacturer for your product. This can be done overseas or here domestically. Foreign companies can often be cheaper than American ones, but either way, every manufacturer in the world must adhere to FDA requirements for a device to be sold in the U.S.
Before you engage a manufacturer, ensure that the company has been approved by the FDA to market your class of device in the U.S. This includes current Good Manufacturing Practices (cGMP), knowledge of packaging and labeling, and experience with U.S. Customs and other issues shipping to the U.S. The wrong manufacturer can mean the difference between getting a safe, compliant device and facing massive fines and losing your business.
Once you have completed the required regulatory filings, you can usually expect some back and forth with the FDA. It may send you a letter asking for clarification or more information about your device. It is always a good idea to have legal counsel to help you navigate this process.
Call us today for more information or to get started getting your device safely and compliantly to market.