On Wednesday, March 15th, FDA’s Center for Biologics Evaluation and Research (CBER) released an updated version of its list of substantially equivalent 510(k) medical device applications.
What is “substantial equivalence”?
“Substantial equivalence means that the new device is at least as safe and effective as the predicate.” According to the FDA, a medical device is considered substantially equivalent if it has the same intended use and technological characteristics as the predicate device. If a medical device has the same intended use as the predicate device but different technological characteristics, it may still be considered substantially equivalent if the information submitted to the FDA:
- Does not raise new questions of safety and effectiveness; AND
- Demonstrates that the device is at least as safe and effective as the legally marketed device.
FDA states that “a claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.”
Declaring Substantial Equivalence
In order to demonstrate that a device is substantially equivalent to another medical device that is legally marketed in the US, a sponsor must submit a 510(k) submission to the FDA. After a 510(k) has been submitted, the applicant may not market the device in question until it has received a letter from the FDA declaring the device substantially equivalent.
As the Agency reviews applications, sometimes it determines that a device is not substantially equivalent. When this happens, the applicant has a few options, which include:
- Resubmit another 510(k) with new data
- Request a Class I or II designation through the de novo process
- File a classification petition
- Submit a premarket approval application (PMA)
FDA’s Updated List
Last week, the FDA updated its list of medical devices that CBER has deemed substantially equivalent as of January 31, 2017. This list is organized in alphabetical order by applicant name, and is updated from time to time to reflect the currently cleared 510(k) clearances.