Yes. There are numerous guidance documents available from FDA that provide recommendations on the non-clinical and clinical testing of specific device types. Additionally, FDA accepts Pre-Submissions, in which you can submit information to FDA and receive advice on topics such as a non-clinical testing plan and/or a draft clinical protocol. Additional information on Pre-Submissions may be found in the final guidance “The Pre-Submission Program and Meetings with FDA Staff.” FDA guidance represents FDA’s approach to this topic.
Additionally, there are two types of early collaboration meetings available that are discussed in “Early Collaboration Meetings Under the FDA Modernization Act (FDAMA)”. These formal interactions (Determination Meetings and Agreement Meetings) are specific to clinical investigations and do not address non-clinical testing or protocols.
