AN ANALYSIS OF CRITICAL FACTORS IN MEDICAL DEVICE DEVELOPMENT TO DESIGN FOR FDA

This paper provides a deeper understanding on the Food and Drug Administration's (FDA) role in relation to medical devices. Specific considerations are given to the data FDA reports to the public domain as part of the 510(k) clearances and PMA approvals. Scientific treatment of such considerations has been a void in the literature prior to the work presented, here. Critical factors are defined at the product level, where an empirical investigation is performed to study the impact of various factors in FDA's decision time. The critical factors identified include regulatory components, product characteristics and the historical reference. Significant regulatory components include the submission types and the different types of classifications (product codes, risk classification and regulation number). Significant product characteristics included the factors specific to hip devices (cemented, constrained) and generalized factors applicable to most medical devices (intended use, context of use, function and material). The importance of historical reference, as an indication of various types of experience, showed the significance of company's experience with FDA, and FDA's experience in terms of product codes and product characteristics (body part, function, material and et cetera).