It can be pretty confusing to look at the medical device regulations to figure out how to submit the appropriate documentation for review, particularly in the light of the many new device programs and guidance being announced monthly. Some of this confusion stems from the history of medical device regulations. Before 1976, devices were regulated in a manner similar to drugs under the Food, Drug, & Cosmetic Act (FD&C Act, passed in 1938 and since amended). The Act was amended in 1976 to create a set of legal requirements specifically for medical devices. Under the device amendments, all devices are classed into 1 of 3 categories, each with their own submission/review pathway.

Class I devices are considered low risk and must follow the general controls requirements (found in 21CFR parts 501, 502, 510, 516, 518, 519, and 520) but may not require submission prior to putting the device on the market. The general controls include requirements for proper labeling, registration of producers, what remedies are available when issues are found, and appropriate recordkeeping and reporting. Examples of class I devices include manual toothbrushes, dental floss, and medical gloves. Those class I devices that require premarket submission use the 510(k) or premarket notification pathway.

Class II devices have moderate risk and must follow both general and special controls requirements under the Act. These special controls are device-specific and are meant to provide the assurance that the device is safe and effective where the general controls are insufficient. Special controls often include device-specific labeling instructions (including instructions for use), premarket data requirements, or postmarket surveillance studies. Most class II devices use the 510(k) or premarket notification pathway. Some examples of class II devices are male condoms, non-invasive blood pressure monitors, or hearing aids.

Class III devices are the highest risk, and in addition to the general and special controls requirements they must be approved under the premarket application (PMA) pathway before they can be placed on the market.  A PMA application contains information about how the medical device was designed and how it is manufactured, as well as preclinical and clinical studies of the device, all of which should demonstrate that the device is safe and effective for its intended use. This is the most expensive pathway because it requires clinical trials. Class III devices include heart valves, automatic external defibrillators, and material for dental bone grafts.

There are other approval pathways such as the De Novo pathway for new devices that are class I or II but there is no previously approved device for comparison in the 510(k) submission, or Humanitarian Device Exemption for class III devices that benefit patients with rare diseases. There are also programs that expedite review under certain pathways like the Breakthrough Device program or the Special 510(k) program. I’ll discuss each of these pathways and their modifiers in future posts. You may also read more about how to study and market your device at this CDRH web site.

Text Copyright © 2019 Katrina Rogers