On July 28, 2014, the U.S. Food and Drug Administration (FDA) released a final guidance entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]. [Final Guidance] The Final Guidance provides industry and FDA staff with explanations about the critical decision points that FDA uses to determine substantial equivalence and is intended to enhance the predictability, consistency, and transparency of the 510(k) program. A draft version of this guidance was published two and a half years ago in December 2011.

In large measure, the Final Guidance carries forward the principal features of the 2011 draft, and indeed, FDA acknowledges that the guidance is “not intended to implement significant policy changes to the current 510(k) review process.” However, FDA noted that sections addressing FDA’s Special and Abbreviated 510(k) programs, which were included in the 2011 draft, would be finalized by the agency separately.

The Final Guidance incorporates four appendices that are particularly useful: (A) a 510(k) Decision-Making Flowchart (which is modified from the draft guidance); (B) the 510(k) Summary Document Requirements; (C) Sample of 510(k) Summary Complying with 21 C.F.R. § 807.92, and (4) a Glossary of Significant Terminology. Additionally, the principles in the final guidance should be supplemented by a careful review of a new draft guidance, issued by FDA on July 14, 2014, outlining the benefit-risk factors FDA considers to determine whether a 510(k) device with different technological characteristics is substantially equivalent.

Overview 

The Final Guidance provides updated information to the existing guidance document entitled “Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3 (K86-3 Guidance), issued on June 30, 1986. The K86-3 Guidance was written and issued as final guidance prior to the February 27, 1997 implementation of FDA’s Good Guidance Practices and has not been updated since its initial publication date. This Final Guidance replaces the K86-3 Guidance.

The Final Guidance, thus, represents FDA’s current recommendations to industry and FDA staff about the content of 510(k) submissions and describes the decision-making process for determining substantial equivalence of devices reviewed under the 510(k) program. The Final Guidance is organized to coincide with the critical decision points outlined in the 510(k) Decision-Making Flowchart in Appendix A, which itself has been updated to track Section 513(i) of the Federal Food, Drug, and Cosmetic Act (FDCA) and relevant regulations more closely. The Final Guidance is not intended to supplant existing device-specific guidance, and FDA notes that the Final Guidance covers broader areas not addressed in the device-specific guidance documents. Also, FDA states that the 510(k) Decision-Making Flowchart is meant to be used only in conjunction with this Final Guidance and not as a “stand-alone” document. In short, the relevant parts of the Final Guidance should be consulted in the context of each critical decision point in the Flowchart.