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by Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process,Theresa Wizemann
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Medicine & Health Sciences
  • Author:
    Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process,Theresa Wizemann
  • ISBN:
    0309162068
  • ISBN13:
    978-0309162067
  • Genre:
  • Publisher:
    National Academies Press; 1 edition (June 10, 2011)
  • Pages:
    132 pages
  • Subcategory:
    Medicine & Health Sciences
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    1544 kb
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  • Rating:
    4.8
  • Votes:
    462
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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.

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

measuring postmarket performance and other select topics : workshop report. 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

measuring postmarket performance and other select topics : workshop report. by Theresa M. Wizemann. Published 2011 by National Academies Press in Washington, . 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.

Strengthening the FDA The scope of responsibilities for the FDA is vast . How we measure 'reads' Committee on the Public Health Effectiveness of the FDA Clearance Process.

Strengthening the FDA The scope of responsibilities for the FDA is vast, complex, and growing, and the agency is hampered by insufficient resources, inconsistent leadership, unclear mandates, and ambiguous and overly ambitious priorities. How we measure 'reads'. Committee on the Public Health Effectiveness of the FDA Clearance Process. Board on Population Health and Public Health Practice.

a Process, Committee on the Public Health Effectiveness of the FDA . Measuring the Quality of Health Care. by: Donaldson, Molla S. Published: (1999).

a Process, Committee on the Public Health Effectiveness of the FDA 510(k) Clearance. Medical Devices and the Public's Health : The FDA 510(k) Clearance Process at 35 Years. by: Process, Committee on the Public Health Effectiveness of the FDA 510(k) Clearance. Challenges for the FDA : The Future of Drug Safety, Workshop Summary. by: Forum on Drug Discovery, Development, and Translation.

Today, the Institute of Medicine (IOM) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance .

Today, the Institute of Medicine (IOM) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process released its long awaited, 245-page report, entitled, Medical Devices and the Public’s Health The FDA 510(k) Clearance Process at 35 Years. The premarket notification, or the 510(k) clearance process, named after Section 510(k) of the authorizing legislation passed by Congress in 1976, is the primary pathway to market for Class II devices.

At the request of the FDA, the IOM examined the 510(k) process and concludes that the FDA’s finite resources should be invested in developing an integrated . Video of the public briefing on the IOM's report Medical.

At the request of the FDA, the IOM examined the 510(k) process and concludes that the FDA’s finite resources should be invested in developing an integrated premarket and postmarket regulatory framework Video of the public briefing on the IOM's report Medical Devices and the Public’s. Food and Drug Administration.

Committee on the Public Health Effective, Board on Population Health and Public He. ISBN-13.

Walmart 9780309158497. Committee on the Public Health Effective, Board on Population Health and Public He.

The IOM is the health arm of the National Academy of Sciences and serves as an independent . The plan included a number of action items and recommendations that FDA intends to implement through 2011 and beyond.

The IOM is the health arm of the National Academy of Sciences and serves as an independent, non-partisan organization that regularly advises federal agencies and other entities on public health matters.

The new technology that we’re seeing holds tremendous public health . These criteria would reflect the safety and performance of modern predicate devices.

The new technology that we’re seeing holds tremendous public health promise for patients. This is a contemporary approach to regulation.

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.