The Applied Technical Services Family of Companies (ATS FoC) is a trusted provider of predicate device selection services. The global medical device market is steadily expanding as demand rises and technology evolves. As the market grows, new medical device manufacturers will arise and offer consumers new products built upon established platforms and technologies. Our services help medical device manufacturers identify predicate devices and establish the pathways needed for their devices to become eligible for sale in the US and European Union (EU).
What is a Predicate Device?
A predicate device is a legally marketed medical device that is a benchmark for evaluating a new device’s safety and effectiveness. In the US, predicate devices are requiresto justify that the subject device is “substantially equivalent” to a device already legally approved for sale. Predicate devices are part of the FDA’s 510(k) clearance process for Class II devices, which is a regulatory pathway that requires manufacturers to show their device is substantially equivalent to a predicate device in area such as indications for use, technological characteristics, sterility, biocompatibility, and mechanical strength. Under the EU Medical Device Regulation (MDR), a predicate device is a lawfully marketed device with valid CE marketing. The MDR requires manufacturers to demonstrate that their proposed device is equivalent to a predicate device with respect to its clinical, biological, and technical characteristics.
About Our Predicate Device Selection Services
Our medical device consulting team provides strategic predicate device selection services that help clients navigate the complexities of the FDA 510(k) and MDR pathways with confidence. Our services help streamline the approval process by helping our clients do the following:
- Establish the purpose and appropriate uses of their proposed device
- Search the FDA 510(k) and EUDAMED databases to find appropriate predicate devices
- Choose a predicate device with similar characteristics, technologies, and functions as the subject device
- Collect performance data, ensuring that the selected predicate device has a reputation for being safe and effective
- Navigate the pre-submission and pre-market submission processes for Class II devices
With experience supporting more than 200 successful FDA 510(k) clearances and a faster-than-average approval timeline, we understand how critical the right predicate device is to the medical device approval process. Our experts work closely with clients to simplify the stressful regulatory journey, ensuring their devices reach the market in a timely manner. Failure to select a proper predicate device can result in long delays and increased stress. Our services help our clients avoid the pitfalls of the regulatory pathway, earn FDA or MDR approval, and establish their product’s credibility with healthcare networks and patients.
Contact Us
Call +1 (888)-287-5227 or submit a web request form to learn how we can support your next medical device submission.
