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

WASHINGTON, D.C. Researchers at the Stanford University Program in Biodesign have released a review of the background, mission and statutory requirements of medical device regulation in the United States. The report, published in the December 2007 issue of the Journal of Medical Devices, highlights the differences between regulations guiding medical devices versus pharmaceuticals and underscores the complexity of the approval process and post-market surveillance administered by the Food and Drug Administration (FDA).

According to the researchers, regulation plays a key role in the design, development and commercialization of new medical technologies, making a comprehensive understanding of the various regulatory requirements and their practical implementation a cornerstone of successful medical device innovation. The major barriers to moving innovative technologies from the bench to the bedside in the safest and most efficient way stem from the lack of precise scientifically based data about testing, regulatory approval and health-economic evaluation processes.

The review is part of an ongoing project at Stanford to examine how medical technology is brought to market, approved for use and subsequently enhanced over time. A key goal of the research is to build a model specific to medical technology that will be of value to current and future government initiatives aimed at enhancing the efficiency and efficacy of the regulatory process for public benefit.

Over the last couple of years, highly publicized recalls of medical devices such as defibrillators and pacemakers have sparked internal debate within the FDA about ways to improve post-market surveillance and adverse event reporting, said Jan B. Pietzsch, Ph.D., Consulting Assistant Professor in the Department of Management Science and Engineering at Stanford, and lead author of the report. By thoroughly mapping the current regulatory process, we can contribute to understanding 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 design, testing, manufacturing and post-market surveillance of medical devices.

  • Manufacturers have specific timeframes in which to report adverse events: five calendar days for device-related death, serious injury or malfunction requiring immediate action; 30 days if no immediate action is required.

  • The medical device reporting system is in the process of being improved through the development of electronic reporting tools, making it easier for manufacturers to relay potential problems.

  • Increased harmonization of international standards between the U.S., the European Union, Australia, Brazil and Canada are intended to improve the integration of medical device product safety and process quality on a global basis.


'/>"/>

Contact: Michael Stewart
michael.stewart@gabbe.com
212-220-4444
InHealth: The Institute for Health Technology Studies
Source:Eurekalert

Related biology news :

1. Americans remain pessimistic about the environment, Stanford-AP survey finds
2. Stanford/Packard researchers find disease genes hidden in discarded data
3. Stanford researchers say climate change will significantly increase impending bird extinctions
4. Stanfords nanowire battery holds 10 times the charge of existing ones
5. Researchers identify proteins involved in new neurodegenerative syndrome
6. Texas researchers and educators head for Antarctica
7. MGH researchers describe new way to identify, evolve novel enzymes
8. University of Pennsylvania researchers develop formula to gauge risk of disease clusters
9. U of MN researchers discover noninvasive diagnostic tool for brain diseases
10. U of Minnesota researchers discover noninvasive diagnostic tool for brain diseases
11. Researchers discover new strategies for antibiotic resistance
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2017)... Feb. 7, 2017 The biometrics market ... the confluence of organizations, desires to better authenticate ... systems (password and challenge questions), biometrics is quickly ... systems. The market is driven by use cases, ... consumer and enterprise uses cases, with consumer-facing use ...
(Date:2/6/2017)... DENVER , Feb. 6, 2017 ... national security are driving border authorities to continue ... Acuity reports there are 2143 Automated Border Control ... Kiosks currently deployed at more than 163 ports ... between 2013 to 2016 achieving a combined CAGR ...
(Date:2/2/2017)... , Feb. 1, 2017  Central to ... and meaningful advances worldwide, The Japan Prize Foundation ... Prize, who have pushed the envelope in their ... and Communication. Three scientists are being recognized with ... achievements that not only contribute to the advancement ...
Breaking Biology News(10 mins):
(Date:2/20/2017)... ... February 20, 2017 , ... Global relationship marketing company ... for full, active membership in the Canadian Direct Sellers Association (DSA) effective immediately. ... Officer Jeff Olson in 2011. Today Nerium International, with its cutting ...
(Date:2/20/2017)... 2017 This report analyzes the worldwide markets for ... Xylanase, Amylase, Cellulase, and Others. The report provides separate comprehensive ... Japan , Europe , ... and Rest of World. Read the full ... are provided for the period 2015 through 2022. Also, a ...
(Date:2/20/2017)... (PRWEB) , ... February 20, ... ... leading US Joint Commission Accredited venture-backed teleradiology and telemedicine company announces at ... Healthineers. USARAD services are planned to be offered via a global cloud-based ...
(Date:2/20/2017)... , Feb. 20, 2017  Former NFL players who ... motor functions later in life, according to a preliminary study ... of Neurology,s 69th Annual Meeting in Boston ... functions are complex movements where the muscles and nerves work ... ...
Breaking Biology Technology: