Institute of Medicine releases study of the FDA 510k process

The Institute of Medicine - IOM - released its study of the FDA CDRH 510k process for Medical Device approval.  The committee recommends that the FDA should invest in developing a new regulatory framework to replace the, quote, flawed 510k medical device clearance process.  They cite that the FDA's limited legal power and resources cause the 510k process to be and unreliable screen for safety and effectiveness of moderate-risk Class II devices.


Their primary concern stems from the use of "substantial equivalence" for a given submission as compared to predicate devices.  The committee stated that "reliance on substantial equivalence cannot assure that devices reaching the market are safe and effective"  They also indicated that "the majority of the devices used as the basis for comparison were never reviewed for safety or effectiveness."  and that "the 510k clearance does not determine a device to be safe or effective."

The IOM committee also indicate that they feel that "It's not clear that the 510k process is serving the needs of either industry or patients, and simply modifying it again will not help," as indicated by committee chair David Challoner, emeritus vice president for health affairs, University of Florida,Gainesville.  He went on to say that "The 510k process cannot achieve its stated goals -- to promote innovation and make safe, effective devices available to patients in a timely manner -- because they are fundamentally at odds with the statutes that govern how FDA must implement the process.  While current information is not adequate to immediately start designing a new framework, we believe the agency can get the necessary data and establish a new process within a reasonable time frame."  As such the committee feels that the 510k process cannot needs to be done away with in favor of some as yet undefined system.

Another area highlighted by the IOM committee is post market oversight.  As indicated from the press release, "The committee found substantial weaknesses in current postmarket oversight of devices and it heard from FDA that the agency faces limitations on its authority to address problems with products on the market."  They also went as far as to indicate that new legislation be enacted to address the lack of authority to enforce postmarket issues; "If necessary, Congress should pass legislation to remove barriers to FDA's use of postmarket regulatory authority."

The committee cited 26 device types classified as "high risk" that are allowed to reach market through the 510k process.  They suggested that the FDA can either reclassify these types into a lower risk category if warranted or require them to go through the PMA process.

Further information From the IOM site is provided via the links below:

Accompanying Letter to the FDA PDF

Press Release HTML

Report Brief PDFReport Brief HTML

Reports: Related Reports

Activities: Related Activities


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