USA – Evidentiary Expectations for 510(k) Implant Devices

As part of FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public
Health (herein referred to as the “Safety Action Plan”), FDA committed to strengthen and
modernize the premarket notification [510(k)] Program. To enhance the predictability,
consistency, and transparency of the 510(k) Program, FDA is issuing this guidance to provide our current thinking on 510(k) submissions for implant devices. This guidance is intended to serve as a primary resource on general recommendations for all implant devices for which a 510(k) is required (510(k) Implants), while device-specific guidances may provide further specificity for a given device type. This document is intended to clarify our evidentiary expectations for 510(k) Implants. By “evidentiary expectations,” we mean that this document is intended to assist industry in design and execution of appropriate performance testing that may be necessary to support 510(k) submissions for implants. It also provides general recommendations for other content, including proposed labeling, to include in these submissions. In addition, some of the recommendations in the guidance, such as those related to identification and mitigation of certain risks associated with implants, may be relevant beyond the context of preparing a 510(k) submission and helpful to consider throughout the total product lifecycle. For purposes of this guidance, a “submitter” is the entity that submits the 510(k) to FDA for review…