US Medical Device Regulation: From 510(k) to PMA

US Medical Device Regulation: From 510(k) to PMA

Written by Dominique Engome Tchupo, Ph.D.
Senior Human Factors Researcher
Jumpseat Research


Process Overview

To market medical devices in the US, they must be approved by the Food and Drug Administration (FDA). It is imperative to know and understand the FDA’s guidance and requirements for device approval as it would be exponentially more costly and time consuming to go back and re-design after a rejection. Therefore, it is necessary to consult with a professional who knows the ins-and-outs of these processes. Depending on your product, you will likely have to take one of many paths to FDA approval. Like many of the main medical device markets, the FDA has three device classes, Class I, Class II, and Class III, with associated risks and complexity of the approval process increasing with class number.     

Class I Medical Devices

Class II devices are considered moderate risks and according to the FDA are “devices for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device”. Examples of Class II medical devices are surgical gloves, blood pressure cuffs, contact lenses, and catheters. These devices typically require the 510(k) prior to going to market, although the 510(k) requirements may vary by device.

Obtaining a 510(k) Premarket Notification 

The 510(k) Premarket Notification is primarily used for Class II devices; however, some Class I or Class III devices need to or can undergo this process too. One of the major requirements of the 510(k) is evidence of substantial equivalence to another legally marketed device in the US. This device used for equivalence is your predicate, and among other requirements, you need to demonstrate that the device for which you seek a 510(k) has the same intended use as the predicate.  

The 510(k) is needed for both new devices and previously approved devices with modifications that can affect their safety or effectiveness. Overall, it can take 9 months or more to get approval through the 510(k) process. 

Class III Medical Devices 

Finally, Class III devices are considered high risk and often novel devices. The FDA defines Class III devices as products that “usually sustain life and are implanted or present a potential unreasonable risk of illness or injury”. Some examples of Class III medical devices are pacemakers, defibrillators, ventilators, and fetal blood sampling monitors. While a rare few might be able to go through the 510(k) if a suitable predicate is found, most of these devices cannot.  

Obtaining Premarket Approval (PMA) 

The Premarket Approval (PMA) is primarily used for Class III devices, but also those for which no predicate found in Class I and Class II. PMA is the most stringent marketing application process required by the FDA, requiring rigorous clinical trials to ascertain the effectiveness and safety of the device. This process takes considerable time 36 months (about 3 years) or more. As part of the PMA, clinical trials are required. 

Considerations for Medical Device Marketing 

Depending on your device, the FDA process for taking your product to market can be long and arduous. Having realistic expectations of timeline and resource commitments early in the design process will pay dividends on the back end. If you are further along in development, there’s no time like the present to get started, or you will likely see tremendous delays to your launch date. If done right, you can even make your product safer and more effective and enjoyable at the same time, killing two birds with one stone!