An Example of US Food and Drug Administration Device Regulation

Abstract

Abstract-The Food and Drug Administration has established requirements for protecting the public health by assuring the safety and effectiveness of a variety of medical products including drugs, devices, and biological products, and for promoting public health by expediting the approval of treatments that are safe and effective. The Center for Devices and Radiological Health is the center within the agency that is responsible for pre-and postmarket regulation of medical devices. In this article, we review current regulation of medical devices, research and development programs, pre-and postmarket perspectives, and future considerations of medical devices, particularly as they relate to devices targeting acute ischemic stroke as an example of the process. We also review the Center for Devices and Radiological Health's historical perspective of acute ischemic stroke trials and clinical trial design considerations used in prior studies that have led to US market clearance as they are related to currently marketed devices indicated for acute ischemic stroke.

Medical Device Regulations: A Current Perspective

“…6 Within FDA, the Center for Devices and Radiological Health (CDRH) is primarily accountable for pre-and postmarket supervision of medical devices in the United States. 7 The United States has adopted a risk-based classification for medical devices wherein the devices are classified according to the risk associated with the use of the device. 6 Devices are classified into a 3-tiered system (Class I-lowest risk; Class II-intermediate risk; Class IIIhighest risk).…”

“…HUD has been discussed in detail in the below mentioned paragraphs on HDE. 7 Now let us discuss premarket notification 510(k) process, PMA Process and HDE.…”

“…Sometimes when there are apprehensions regarding safety and effectiveness, the FDA can demand clinical data for 510(k) clearance. 6,7,11 What is PMA process? PMA is a process of review to assess the safety and efficacy for all class III devices.…”

“…A class III device that fails to meet PMA requirements is considered to be adulterated under section 501(f) of the FD&C Act and cannot be marketed. 7,12 What is HDE? HUDs are marketed for a small population through an entirely separate regulatory process called as HDE.…”

“…Hence, investigators are compelled to get permission from their Institutional Review Boards for use of the device in each case. 7 Two examples of devices given marketing approval through HDE are the Argus ® II Retinal Prosthesis System meant for patients of 25 years or more with minimal or no light perception vision due to advanced retinitis pigmentosa and Berlin Heart EXCOR ® Pediatric Ventricular Assist Device (VAD) meant for pediatric patients with severe isolated left ventricular or biventricular dysfunction needing a cardiac transplant and circulatory support. 13 …”