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IOM to Release Its Recs on 510(k): Get up to Speed on the Developments So Far

The IOM will release its 510(k) report and hold a public briefing this Friday. The report is titled "Medical Devices and the Public's Health: The 510(k) Clearance Process at 35 Years." It's unclear at what time the report will be released but the public briefing is scheduled for Friday, 7/29 at 11:00 AM EDT.  Register for the webcast.

What's at Stake with 510(k)s

Seven items from FDA's Working Group on 510(k) were left unfinished when FDA unrolled its plan in January 2011. FDA is waiting for IOM's recommendations on the following issues:

IOM Topic What it Means   
Rescission Authority To consider defining the scope and grounds for the exercise of the Center’s authority to fully or partially rescind a 510(k) clearance.
Postmarket Surveillance Authorities To seek greater authorities to require postmarket surveillance studies as a condition of clearance for certain devices.
Establish a Class IIb To develop guidance defining “class IIb” devices for which clinical information, manufacturing information or, potentially, additional evaluation in the postmarket setting would typically be necessary to support a substantial equivalence determination.
Predicate Clarification To clarify when a device should no longer be available for use as a predicate.
Clarify and Consolidate Regulatory Terms To consolidate the concepts of “indication for use” and “intended use” into a single term, “intended use”.
Device Review To consider the possibility of requiring each 510(k) submitter to keep at least one unit of the device under review available for CDRH to access upon request.
Off-Label Use To explore the possibility of pursuing a statutory amendment that would provide the agency with the express authority to consider an off-label use when determining the “intended use” of a device.

Further Reading

2011: The Year of the 510(k)
February 17, 2011

The New 510(k) Roundup: What You Need to Know
January 20, 2011

John Kerry Defends 510(k)s to Hamburg
April 15, 2011

Senator tells FDA to Seek Medical Device Industry's Expertise Before Changing 510(k) Process
June 24, 2011

Continuing Evolution of the US FDA 510(k) Process

October 1, 2010

GAO: FDA Clearing Too Many High-Risk Devices Through 510(k) Process

April 14, 2011

—Heather Thompson

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