The FDA and Ensuring Safety and Effectiveness of Devices, Biologics, and Technology

Jonathan R. Dubin, MD; Hiba Ibad, MD; Akin Cil, MD; Martha Murray, MD

Disclosures

J Am Acad Orthop Surg. 2022;30(14):658-667. 

In This Article

Abstract and Introduction

Abstract

Orthopaedic devices account for nearly 20% of all devices on the market, with more than 600 novel orthopaedic devices cleared or approved by the FDA for marketing in the United States annually. Advances in technology and biologic therapies offer tremendous potential for patients with musculoskeletal ailments; however, it is important that the safety and effectiveness of these products be assessed to safeguard the public health. The FDA uses multiple different premarket pathways for devices, biologics, and combination products based on perceived risk of the novel product. More than 97% of orthopaedic devices go through the FDA's 510(k) pathway, which does not require clinical trials. The remaining high-risk devices must receive premarket approval and submit clinical trial data demonstrating safety and effectiveness. Similarly, high-risk biologics must obtain a biologics license application by submitting clinical trial data. Postmarketing surveillance strategies, including extended clinical trials or real-world evidence from registries, are increasingly being relied on by the FDA to expedite approval while also improving its capacity to identify problematic products.

Introduction

Orthopaedic devices account for nearly 20% of all devices on the market, with more than 600 novel orthopaedic devices cleared or approved by the FDA for marketing in the United States annually.[1,2] Advances in technology and biological therapies offer tremendous potential for patients with musculoskeletal ailments; however, it is important that the safety and effectiveness of these products be assessed to safeguard the public health. The FDA uses multiple different premarket pathways for devices, biologics, and combination products based on perceived risk of the novel product.[3–5] It also relies on several postmarketing surveillance strategies to identify problematic products.[6,7] It is important for orthopaedic surgeons to familiarize themselves with device regulation, so they can understand basic standards of safety and effectiveness required by the FDA for the products and devices they use in practice. The purpose of this review was to provide a general overview of the FDA regulatory framework and to educate surgeons on how to engage in postmarket surveillance programs.

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