A letter from CDRH dated March 4, 2013, contains the response to my Citizen Petition FDA-2012-P-0747 which called for an investigation into whether Form FDA 3429 Classification Questionnaire conformed to the definition of Class III in the law.

The agency granted my petition, and acknowledged that changes in the Form were needed "to more closely align the form" with the law.

While I was pleased that my petition was granted, there is no cause to celebrate.

The letter stated "FDA is aware of no devices that have been misclassified into Class III as the result of Form FDA 3429."  This may be technically correct since we don't know the exact contents of the Classification Questionnaire in use at the time a device was classified.  I am still seeking copies of the Form as it existed between 1977 and 1997.  If you have access to forms in use between 1977 and 1997, please contact me.

In April 2013, I obtained information from the Office of Management and Budget which shows that the Classification Questionnaire was revised at least four times (in 1984, 1989, 1998, and 2012).  The changes for each of these events are described as "No material/nonsubstantive change to a currently approved collection" in the OMB Control Number History for Control Number 0910-018.  The so-called non-material/non-substantive change" in 2012 consisted of omitting question 4 and column 3 from the form; I consider the July 2012 revisions to be significant.

OMB was unable to provide the actual content for any of the older Questionnaires, and I have been unable to obtain any from the FDA prior to 1997.  We are left to wonder what the changes were in 1984, 1989, and 1998.

On February 28, 2013, Dr. Shuren aske me to provide to the Deputy Director For Policy/CDRH the list of devices which I think may have been misclassified.  The list 17 devices was emailed to her the same day.

In my opinion (as a biomedical engineer) none of the 17 devices is life-sustaining or life-supporting; for a use which is of substantial importance in preventing impairment of human health; or presents a potential unreasonable risk of illness or injury.

To see the CDRH response to my citizen petition, click on the icon unless the letter appears.

copyright 2013 Leroy L. Hamilton