Prior Attempts to Include Materials in Device Labeling

The broad framework FDA has laid out would bring a dramatic change to the case-by-case approach FDA has traditionally taken. Distinct from the approach FDA is now considering, FDA has previously advised manufacturers to list certain materials in the device on the labeling based on case-by-case public health needs. For example, in 2003 FDA developed a labeling regulation that requires disclosure on medical device labeling if the product contains natural rubber latex.9 This labeling regulation was a public health measure prompted by FDA’s learning of increased deaths associated with sensitivity to natural latex contained in medical devices. More recently, FDA recommended including an allergen warning on nitinol-containing device labeling.10 Nitinol is an alloy of nickel and titanium that is extensively used in cardiovascular devices. This labeling recommendation was prompted by the industry’s increased use of nitinol in devices and by nitinol’s complex and unique properties distinct from conventional metals such as stainless steel and titanium. FDA has also recommended including material lists on labeling for breast implants, including “chemicals that might be released from breast implants, and heavy metals present in breast implants” along with “context to the levels of risk/exposure of the chemicals and heavy metals listed.”11 This labeling recommendation was prompted by FDA’s learning of new information regarding risks of breast implants and by concerns that some patients were not receiving and/or understanding information regarding the benefits and risks of breast implants. Outside of these circumscribed materials and devices, FDA has recommended that labeling intended for patients should “list materials in the device so patients with hypersensitivities can easily identify their risks.”12 Patient labeling, however, is not currently required by FDA for all medical devices, but rather is recommended only for a subset of devices such as those operated by patients and their caregivers.