Predicate Creep Report


In February, 2010, CDRH sponsored a public meeting titled "Strengthening the Center for Devices and Radiological Health's 510(k) Review Process."  I presented a talk at the meeting showing extreme examples of "predicate creep."

Contact me for information if you would like to view my presentation or any part of that meeting, or you can find it yourself on the internet.

In addition, I filed a 15-page comment with CDRH.

The report is available at www.regulations.gov, under Docket No. FDA-2010-N-0054-0080.  You can examine or download the report at no charge.  There is an error in end note 4.  It should read "ILX devices are not implants, life-supporting or life-sustaining."

If you wish to have the report emailed or mailed to you, contact me.  There will be a modest charge (under $5).