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Stanford researchers publish review of US medical device regulation
Date:1/10/2008

the entire complex process of medical device innovation and how it can be improved for manufacturers, and more importantly, for patients.

The FDAs Center for Devices and Radiological Health (CDRH) is currently taking steps to improve the post-market surveillance, researchers note, including strengthening the condition of approval studies; improving medical device reporting; focusing on risk-based inspections; implementing third-party inspections; communicating risk/benefit information; and refining the FDAs communications strategy.

Distinction from Drug Regulation

In contrast to pharmaceuticals, medical devices are evaluated using a risk-based classification system that determines its regulatory pathway. Devices are placed into one of three classes: Class I devices, representing low-risk items such as examination gloves do not require performance standards; medium and high-risk devices (Classes II and III) such as infusion pumps and defibrillators follow specific regulatory requirements that vary substantially.

By using a risk-based system, said researchers, the FDA recognizes that some degree of risk is inherent in the development of devices, and further, that all hazards cannot be eliminated. There is often little or no prior experience on which to base judgments about safety and effectiveness; devices undergo performance improvement modifications during clinical trials; and results depend on the skill of the user.

Other key points from the review include:

  • Class III devices are subject to the most stringent controls and require pre-market approval (PMA) to ensure safety and effectiveness of the devices.

  • The PMA program and 510(K) pre-market notification program resemble the regulatory pathways often referred to by industry.

  • The FDA quality systems regulations (QSR) define in clear terms the specific requirements manufacturers need to follow in de
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Contact: Michael Stewart
michael.stewart@gabbe.com
212-220-4444
InHealth: The Institute for Health Technology Studies
Source:Eurekalert

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