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

Type: Consensus Study
Topics: Public Health, Quality and Patient Safety
Board: Board on Population Health and Public Health Practice

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Activity Description

An IOM committee is reviewing the 510(k) clearance process for medical devices. Also known as premarket notification, section 510(k) of the Federal Food, Drug, and Cosmetic Act requires manufacturers of medical devices to notify the Food and Drug Administration (FDA) of their intent to market a medical device at least 90 days in advance. This window of time allows FDA to evaluate whether the device is "substantially equivalent" to a product already on the market, in which case the device does not need to go through the pre-market approval process.

The committee will assess whether the 510(k) clearance process sufficiently protects patients and promotes public health. Specifically, the IOM committee will answer two principal questions:

  1. Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
  2. If not, what legislative, regulatory, or administrative changes are recommended to optimally achieve the goals of the 510(k) process?

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