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FDA Commissions Outside Review Of Device Approval Process

Sep 24, 2009 | Parker Waichman LLP The U.S. Food and Drug Administration (FDA) just announced it commissioned the Institute of Medicine (IOM) to study the pre-market notification program used to review and clear certain medical devices marketed in the United States.

The study will examine the program, also called the 510(k) process, for medical devices, which can be accessed here.  The 510(k) process was established under the Medical Device Amendments of 1976 to ensure safe and effective devices are made available to consumers and to promote innovation in the medical device industry.

The FDA announced that while the study is underway, its Center for Devices and Radiological Health (CDRH) will convene an internal working group to evaluate and improve the consistency of FDA decision-making in the 510(k) process. Established by the National Academy of Sciences, the IOM provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. As part of its study, the IOM will convene a committee to answer:
  • Does the current 510(k) process optimally protect patients and promote innovation in support of public health?
  • If not, what legislative, regulatory, or administrative changes are recommended to achieve the goals of the 510(k) process?

The $1.3 million IOM review is scheduled for completion in 2011, and is one of six priorities outlined for CDRH as well as to:
  • Create an internal task force on the use of science in regulatory decision-making
  • Develop an effective compliance strategy
  • Optimally integrate pre- and post-market information
  • Increase transparency in decision-making
  • Establish clear procedures to resolve differences of opinion
  • Ensure the IOM will hold two public workshops during the next nine months as part of its review and publish a final report in March 2011 containing its conclusions and recommendations

The FDA classifies medical devices into three categories according to their risk level. Class III devices represent the highest risk level and generally require pre-market approval to support their safety and efficacy prior to marketing. Class III devices include heart valves and intraocular lenses. Class I and II devices pose lower risks and include adhesive bandages and wheelchairs. Most Class II and some Class I devices can be marketed after submission of pre-market notifications (510(k) applications) that support their substantial equivalence to legally marketed devices that do not require pre-market approval. Devices that present a new intended use or include new technology that presents new questions of safety or effectiveness may not be found substantially equivalent and require pre-market approval.

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