Skip to main content

Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report

View Cover

Public Health Effectiveness of the FDA 510(k) Clearance Process

Measuring Postmarket Performance and Other Select Topics: Workshop Report (2011)
Purchase Options
Purchase Options MyNAP members save 10% online. Login or Register
Overview

Contributors

Description

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.

Topics

Suggested Citation

Institute of Medicine. 2011. Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report. Washington, DC: The National Academies Press. https://doi.org/10.17226/13020.

Import this citation to:

Publication Info

132 pages | 6 x 9
ISBNs:
  • Paperback: 978-0-309-16206-7
  • Ebook: 978-0-309-21511-4
DOI: https://doi.org/10.17226/13020
Contents
Rights

Copyright Information

The National Academies Press and the Transportation Research Board have partnered with Copyright Clearance Center to offer a variety of options for reusing our content. You may request permission to:

  • Republish or display in another publication, presentation, or other media
  • Use in print or electronic course materials and dissertations
  • Share electronically via secure intranet or extranet
  • And more

For most Academic and Educational uses no royalties will be charged although you are required to obtain a license and comply with the license terms and conditions.

Click here to obtain permission for Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report.

Translation and Other Rights

For information on how to request permission to translate our work and for any other rights related query please click here.

Copyright.com Customer Service

For questions about using the Copyright.com service, please contact:

Copyright Clearance Center
22 Rosewood Drive
Danvers, MA 01923
Tel (toll free): 855/239-3415 (select option 1)
E-mail: info@copyright.com
Web: https://www.copyright.com
Stats

Loading stats for Public Health Effectiveness of the FDA 510(k) Clearance Process: Measuring Postmarket Performance and Other Select Topics: Workshop Report...