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

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

Balancing Patient Safety and Innovation : Workshop Report

eBook - 2011
Rate this:

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.

Publisher: Washington, D.C. : National Academies Press, c2011.
ISBN: 9780309162067
Branch Call Number: ELECTRONIC BOOK
Characteristics: 1 online resource (xiv, 118 p.) : ill. (some color)
Alternative Title: FDA 510(k) clearance process
Call Number: ELECTRONIC BOOK

Opinion

From the critics


Community Activity

Comment

Add a Comment

There are no comments for this title yet.

Age

Add Age Suitability

There are no ages for this title yet.

Summary

Add a Summary

There are no summaries for this title yet.

Notices

Add Notices

There are no notices for this title yet.

Quotes

Add a Quote

There are no quotes for this title yet.

Explore Further

Subject Headings

  Loading...

Find it at KCLibrary

  Loading...
[]
[]
To Top