Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.

Since the FDA Modernization Act of 1997, recent legislation has sought to establish performance goals and consistency in the regulatory review and clearance of new medical devices. Despite these goals, regulatory review times have varied dramatically for devices seeking clearance through the 510(k) pathway; devices that are by definition "substantially equivalent" to other devices previously cleared by the FDA and currently on the market. The goal of this thesis is to investigate the factors that impact the ability for a company to obtain a 510(k) clearance in a predictable timeframe and assess the most important factors that influence time to clearance. The Medical Device industry is a dynamic and rapidly evolving sector that presents complex challenges to regulatory oversight. The 510(k) program and larger device regulatory process has endured the test of time and is well structured to address these challenges. This research focuses on the 7,481 510(k) "substantially equivalent" clearances during the period from October 1, 2007 through June 30, 2010 (FY08 - Q3FY10) in order to analyze the variables that impact clearance times. By testing various hypotheses about the most important factors I aim to provide the device community with the data and suggestions for improving confidence around a particular 510(k) submission's likely approval time. I performed subset analyses on the dataset, segmenting clearances by the type of 510(k) (traditional, abbreviated, and special), clinical category, fiscal year of clearance, use of 3rd party review, submission volume, and product diversity according to clinical category. The results show a distinct increase in clearance time from FY08 to FY10 and suggest that recent scrutiny of the FDA premarket review process may be affecting the efficiency of the Agency FDA review process for medical devices. Further, the 3rd party review program is under-utilized with only 14%, on average, of eligible devices gaining clearance through this process. Through a discussion of two specific critiques of the 510(k) process, namely a recent Government Accountability Office study and an article by the Public Citizen (a public advocacy group), the potential implications of regulatory reform is explored from both a policy and industry perspective.