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FDA premarket approval process of medical devices to be reviewed
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The U.S. Food and Drug Administration has commissioned the Institute of Medicine to evaluate the current 510(k) premarket notification protocol used to review and approve certain medical devices for marketing in the United States, the agency announced.
The study, which is expected to cost $1.3 million, will attempt to determine if the current 510(k) process protects patients and promotes innovations to support public health at an optimum level. If the review finds deficiencies in the current 510(k) protocol, the Institute of Medicine (IOM) will recommend the necessary legislative, regulatory and administrative modifications to the program, according to a press release from the FDA.
To coincide with the study, the FDA’s Center for Devices and Radiological Health (CDRH) will also assemble its own task force to appraise and improve the consistency of the decision-making behind the 510(k) process.
“Good government conducts periodic reviews and evaluations of its programs,” Jeffrey Shuren, MD, acting director of the CDRH, said in the FDA release. “Our working group and the IOM’s independent evaluation will help us determine how the 510(k) process can be improved to better support the FDA’s mission to protect and promote the public health.”
The IOM review is one of six priorities Shuren has earmarked for the CDRH. The others include the creation of an internal task force on the use of science in regulatory decision-making; the development of an effective compliance strategy; the integration of premarket and postmarket information; increased transparency in decision-making; and the establishment of procedures to resolve differences of opinion.
The 510(k) protocol was founded under the Medical Device Amendments of 1976 to promote safe and effective medical innovations in the United States. However, according to the FDA, dramatic shifts in the medical device industry over the past 30 years call for the CDRH to reappraise the adequacy of the premarket approval program.
Over the next 9 months, the IOM will sponsor two public workshops as part of its review and expects to publish its findings in March 2011.