Submitted by kBLASTER Team on
Final Guidance was published by FDA on July 28, 2014 titled The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notification [510(k)]. As reported in previous posting, guidance recommends the identification of a single primary predicate in all 510(k) submissions, has ruled that the use of "split predicates as inconsistent with the 510(k) regulatory standard" and states if multiple predicates are used each predicate used must have identical intended use. This guidance also discusses the new term of “reference devices” in 510(k) submissions and the following excerpts were taken from this guidance which further clarify the use of reference devices:
--“When demonstrating substantial equivalence in a 510(k) submission, manufacturers sometimes direct attention to similar situations FDA has encountered in the past. If a manufacturer successfully navigates through Decision Point 4 on the Flowchart using a single predicate device, other legally marketed devices, which FDA calls “reference devices,” may be used to support scientific methodology or standard reference values at Decision Point 5a.
--"It is important to note that a reference device is not considered a predicate device and it cannot be used to address Decision Points 1 – 4 on the Flowchart. Additionally, the applicability of a reference device will need to be reviewed by FDA for its appropriateness. If a selected reference device is used in an anatomical location or for a physiological purpose that is considerably different than that of the new device, its utility as a reference device may be limited."
--"If a manufacturer intends to use a reference device, the manufacturer should provide a scientific rationale that justifies its use.”
--"Appendix D. Glossary of significant terminology. The following terms are defined for purposes of this guidance:
Reference Device – A legally marketed device that is intended to provide scientific and/or technical information (e.g., test methodology) to help address the safety and effectiveness of a new technological characteristic. Reference devices are not predicate devices and may only be used after Decision Point 4 on the 510(k) Decision-Making Flowchart.