Leroy Hamilton says FDA's habit of publishing information about medical device categories using the name of the device without the associated product code can be confusing.
By Jim Dickinson
FDA should include product codes in notices and other information published for specific categories of medical devices, according to a citizen petition from former CDRH engineer Leroy Hamilton.
When CDRH set up the former Office of Medical Devices and Diagnostic Products it assigned a three-letter code to each category of medical devices. The codes are a “very efficient tool for anyone seeking information in the various databases (Registration and Listing, 510(k), PMA, MAUDE, etc.),” the petition says.
“Currently, FDA frequently publishes information about specific categories of device in the Federal Register or on the FDA Web site using the name for the device without mentioning the associated [p]roduct [c]ode. This can be confusing at times,” the petition says. “For example, ‘transcutaneous electric nerve stimulator’ or TENS units[,] have ten different product codes... If the FDA would cite the product code in public notices [that] are pertinent to specific medical devices, the public would know explicitly which devices are included. This would reduce confusion and expedite searches for information in the CDRH databases.”
Two years ago, Hamilton was successful in getting CDRH to revise its device classification questionnaire to bring it in line with statutory definitions. In granting that petition, the center agreed that the classification questionnaire (Form FDA 3429) “did not account for devices that are not for use in supporting or sustaining human life, are not for a use [that] is of substantial importance in preventing impairment of human health, and do not present a potential unreasonable risk of illness or injury, but are devices for which insufficient information exists to determine that general controls are sufficient to provide a reasonable assurance of safety and effectiveness or to establish special controls to provide such assurance.”
Hamilton’s petition argued that the old form wrongly guided agency employees and advisory committee members to a classification conclusion because it didn’t conform to the statutory definition for Class III devices. He said he repeatedly attempted to communicate this problem to CDRH personnel, including the ombudsman’s office, and by making presentations at two advisory committee meetings.
“Petitioner’s efforts to engage CDRH personnel in a discussion of the subject of this petition have been rebuffed,” he wrote.
Jim Dickinson is MD+DI's contributing editor.