The Risk Recalled Predicates Pose in 510(k) Submissions

A woman uses a medical device as she thinks on the potential recalls that her 510(k) submissions could cause.

New studies have found that medical devices citing predicates in their 510(k) submissions are more likely to be recalled if the predicates have previously been recalled. The research, conducted by the University of Minnesota and published in the Journal of the American Medical Association on January 10, 2023, evaluated the correlation between cited predicates and new devices. Some researchers believe this means the regulations for citing predicates on 510(k) submissions need to be updated. 

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Predicates and 510(k) 

The U.S. Food and Drug Administration (FDA) defines a 510(k) as “a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.” This is also referred to as a “predicate” device.  

 A premarket notification 510(k) is required when medical device companies:  

  • Introduce a device to distribute commercially for the first time 
  • Change or modify a device that significantly affects its safety or effectiveness 

Submitters must compare their device to one or more similar predicates, and their 510(k) submission must support the claim that the new device is substantially equivalent (SE) to the predicate. 

When FDA determines a new device to be SE to the predicate, it sends the submitter an order. The order, in the form of a letter, states the device can be marketed in the U.S. FDA’s order clears the device for commercial distribution. 

Want to learn more about how predicates are used to establish SE? Read Medical Devices 101: Premarket Notification 510(k). 

Recalled Devices as Predicates 

Medical device companies can cite any legally marketed device as a predicate, even those subject to Class 1 recalls.  

The University of Minnesota studies analyzed the likelihood of a new device being recalled when the cited predicates were subject to recalls. The study looked at more than 35,176 medical devices that had received 510(k) clearance between 2003 and 2018. 

The researchers evaluated factors in the predicates, such as recall status and age, and observed the likelihood that a new device would be recalled. The research concluded that certain characteristics of the predicates corresponded to a higher likelihood that the new devices would be recalled. 

If a predicate had three or more ongoing recalls, the new device was 81.2% more likely to be recalled compared to the average recall probability. 

The Call for Updated Regulations 

Additional research is needed; however, researchers have differing opinions about whether their studies indicate the need for updated regulations. 

While some researchers state that various factors should be considered when deciding whether to update regulations, others believe that safeguards are needed to improve predicate selection and ensure patient safety. 

 

Get assistance with FDA compliance.

Registrar Corp’s Regulatory Specialists help companies comply with FDA requirements, including regulations for Medical Devices. 

For more assistance with FDA regulatory requirements, call: +1-757-224-0177, email: info@registrarcorp.com, or chat with a Regulatory Advisor 24-hours a day: www.registrarcorp.com/livechat.

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