Posted By: Stephanie Bouzounis, Senior Communications Specialist
The 510(k) Process
In alignment with FDA’s overall vision to improve various processes, there will be updates to the 510(k) process this year. Before the updates are mentioned, a background of this necessary process for medical device manufacturers must be understood.
Under section 510(k) of the FDA Modernization Act (FDAMA) of 1997, “a person who intends to introduce a device into commercial distribution is required to submit a premarket notification or 510(k), to FDA at least 90 days before commercial distribution is to begin.” Furthermore, 21 CFR 807.87 gave the FDA the authority to establish the content requirements for premarket notifications submitted by device manufacturers. The FDA Modernization Act of 1997, also known as FDAMA, in conjunction with the Medical Device Amendments of 1976, allows for the FDA to exempt generic types of medical devices from premarket notification – unless the device is intended for use of “substantial importance”.
Types of Devices
Medical devices are categorized in three different classifications: Class I, Class II, and Class III. Class I medical devices are low risk. These are devices that are not intended to treat potentially fatal diseases. Many of these devices are available as over-the-counter products in pharmacies across the country. Bandages, dental floss, latex gloves are all examples of a Class I device. Class II medical devices are moderate risk. These devices do not generally treat potentially fatal diseases but may cause harm if someone were to misuse them. These devices are also not implantable. Class III medical devices are high-risk devices. Their purpose is to support life, important in preventing impairment to human health, and can cause serious injury or death if used improperly. Some examples of Class III devices are: pacemakers, hip replacements, and stents.
The Approval Process
Medical Device Manufacturers must register their intent to market a medical device with the FDA at least 90 days in advance. This is known as Premarket Notification (PMN). During this 90-day period, the FDA determines whether the device is equivalent to one that is already on the market, and which category the device would fall into. According to the FDA, medical device manufacturers are required to submit a PMN if they intend to introduce a novel device into the market or redistribute a device that has been significantly modified to the extent safety or effectiveness could be changed. In an article from the European Medical Device Technology magazine titled “The Evolving US 510(k) Review Process” by Dr. Marie E. Donawa, it stressed that medical device manufacturers must understand all the regulatory requirements set forth by CDRH, the Center for Devices and Radiological Health. General guidances should be identified and followed through. In fact, there were two recent guidances released by the FDA on October 25, 2017, titled “Deciding When to Submit a 510(k) for a Change to an Existing Device” and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device”. While FDA guidances are not law, these are documents that describe the FDA’s thinking on a topic. These are suggestions but not requirements. The 510(k) process is also affected by MDUFA, or the Medical Device User Fee Amendment. MDUFA IV has recently been passed. Under MDUFA IV, the 510(k) process would cost $10,566 with a small business fee of $2,642. A PMA, which is needed for Class III devices, will now cost $310,764 with a small business fee of $77,691.
One of the updates to the 510(k) process was mentioned above – and that is the cost. The cost has increased for 2018. Another change that will be coming down the pike is an anticipated guidance from the FDA that will address comparison testing. Innovative medical devices potentially do not have an equivalent device on the market for it to be compared to. Dr. Scott Gottlieb, FDA Commissioner, stated that this new approach will use modern criteria as the reference standard and device manufacturers could meet objective safety and performance criteria in place of equivalence testing. Recently, CDRH published metrics for third-party 510(k) reviews in an effort to comply with changes under the FDA Reauthorization Act (FDARA). The FDA is going to publish draft guidance on whether Class I and Class II devices require third-party reviews, and by the end of 2018, issue a draft guidance on reaccreditation for third party reviewers.
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For further reading, check out some of our blogs on medical devices: