The Applied Technical Services Family of Companies (ATS FoC) offers expert‑driven predicate device consulting services to support manufacturers navigating the FDA and EU medical device approval landscapes. The development of new medical devices is a detailed, complex process that often requires expert opinion to ensure success. Our team helps clients select predicate devices to gain FDA and EU approval for their new medical device designs.
Understanding Predicate Devices
A predicate device is an existing, legally marketed medical device that manufacturers of a new device use as a reference to demonstrate the safety and effectiveness of their new product. The FDA’s 510(k) framework requires that manufacturers of subject devices establish how their device is substantially equivalent to a predicate device. This includes proving how the two products have closely related uses, technologies, mechanical strength, biocompatibility, and sterility. Establishing an FDA-approved predicate device is central to the 510(k) submission and approval process, which must be completed for a device to be eligible for marketing and sale in the United States. The EU Medical Device Regulation (EU MDR) does not share the FDA’s “predicate device” system; instead, it requires that manufacturers demonstrate their device’s equivalence to a pre-existing CE-marketed device. This process requires extensive evidence that the two devices share biological, clinical, and technical characteristics.
About Our Predicate Device Consulting Services
Our predicate device consulting services help our clients navigate the EU MDR and FDA 510(k) submission processes, minimizing uncertainties along the path to FDA and EU approval. Our consultants work closely with clients to:
- Clarify the intended purpose, clinical application, and intended uses of the subject device
- Conduct thorough searches of the FDA 510(k) and EU databases to identify viable predicate devices
- Evaluate potential predicates for similarity in design, technology, and performance
- Rationalize the selection of the predicate device or devices
- Review available performance data, ensuring the predicate has a strong record of safety and effectiveness
- Guide the manufacturers of Class II devices through pre‑submission and pre-market submission processes
Contact Us
Call +1 (888)-287-5227 or submit an online request form for more information about how our predicate device consulting services can support your next FDA or EU MDR submission.
