Decision Diagnostics Corp (DECN)

[Raffis]

READ NOW IT MAKES SENSE: 3. Definitions and Scope
https://www.fda.gov/media/81784/download
For the purposes of this guidance, clinical study types are defined as follows:3
? An early feasibility study is a limited clinical investigation of a device early in
development, typically before the device design has been finalized, for a specific indication (e.g., innovative device for a new or established intended use, marketed device for a novel clinical application). It may be used to evaluate the device design concept with respect to initial clinical safety and device functionality in a small number of subjects (generally fewer than 10 initial subjects) when this information cannot practically be provided through additional nonclinical assessments or appropriate nonclinical tests are unavailable. Information obtained from an early feasibility study may guide device modifications. An early feasibility study does not necessarily involve the first clinical use of a device.
? A first in human (FIH) study is a type of study in which a device for a specific indication is evaluated for the first time in human subjects. This document only discusses FIH studies that meet the definition of an early feasibility study.
? A traditional feasibility study is a clinical investigation that is commonly used to capture preliminary safety and effectiveness information on a near-final or final device design to adequately plan an appropriate pivotal study. Because the study of a near-final or final device design takes place later in development than an early feasibility study, FDA would expect to see more nonclinical (or prior clinical) data in a traditional feasibility study IDE application.4 A traditional feasibility study does not necessarily need to be preceded by an early feasibility study.
? A pivotal study is a clinical investigation designed to collect definitive evidence of the safety and effectiveness of a device for a specified intended use, typically in a statistically justified number of subjects. It may or may not be preceded by an early and/or a traditional feasibility study.
Early feasibility studies may be conducted for multiple reasons, such as obtaining initial insights into:
? the clinical safety of the device-specific aspects of the procedure;
? whether the device can be successfully delivered, implanted or used;
? operator technique challenges with device use;
? human factors (e.g., difficulties in comprehending procedural steps);
? the clinical safety of the device (e.g., evaluation of device-related serious adverse events);
? whether the device performs its intended purpose (e.g., mechanical function, making
intended measurements);
3 In this guidance, the term ‘feasibility’ is considered synonymous with ‘pilot.’ For consistency purposes, ‘feasibility’ is the term that should be used in reference to the types of clinical studies that precede the pivotal study phase.
4 Additional nonclinical testing could be completed concurrent with conducting the early feasibility study if needed to support the conduct of a traditional feasibility or pivotal study.
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Contains Nonbinding Recommendations
? device failures;
? patient characteristics that may impact device performance (e.g., anatomical limitations);
and
? therapeutic parameters (e.g., energy applied, sizing, dose released) associated with device
use.
Unlike traditional feasibility studies, which are focused on providing initial clinical safety and effectiveness information for a near final or final device design or capturing data to guide the development of a pivotal study, early feasibility studies have a broader purpose. Early clinical experience obtained from an early feasibility study increases the efficiency of the device development process, as it may be used to:
? identify appropriate modifications to the procedure or device; ? optimize operator technique;
? refine the intended use population;
? refine nonclinical test plans or methodologies; and
develop subsequent clinical study protocols