In FDA Substantial equivalence means to demonstrate a new device to be marketed is safe and effective with a predicate device for the premarket submissions. Substantial equivalence doesn’t require the predicate device and the subjective device are identical rather it can be demonstrated through intended use, design, materials, performance, safety, effectiveness, labeling, biocompatibility, and other applicable characteristics. Substantial equivalence can be claimed to a pre-amendment or post amendment device that is legally marketed.
What is pre-amendments and post amendments device? And how effectively use a predicate device?
The pre-amendments device refers to devices which legally marketed in the U.S. before May 28, 1976. Devices for those regulation requiring a PMA application and has not been published by FDA and which have not been changed or modified significantly since then
If devices which are meeting the above criteria are called “grandfathered” devices and doesn’t require 510(k). The device should have the same intended use as of marketed product before May 28, 1976. If the device has a different intended use, then it falls under a new device and a 510(k) should be submitted to FDA for marketing clearance.
Post amendment devices refer to the medical devices which are marketed after May 28, 1976. In view of change in medical technology significantly since 1976, nearly all 510 (k) submissions claiming substantial equivalence to a post amendment device got cleared under the 510 (k) process recently.
Identifications of primary predicate device which is most similar to the device under review with respect to indications for use and technological characteristics shall be done by manufacturers. More than one predicate device may be identified by submitter to assist in demonstrating substantial equivalence in certain circumstances. Using split predicates are not consistent with the 510 (k) regulatory standard. In some cases Reference devices will be identified by manufacturers to support scientific methodology or standard reference values in their 510 (k) submission.