English
The framework laid out by FDA would make significant changes to current medical device labeling requirements. FDA regulations have historically required medical device labeling to include the manufacturer name and place of business, intended use of the device, and adequate directions for use of the device.2 FDA has long advised manufacturers that device labeling must include sections regarding the device’s indications for use, contraindications, warnings, precautions, special patient populations, and adverse reactions.3 While FDA has advised that the “contraindications” section of the labeling should note if there is a known hypersensitivity to a material in the device, FDA has generally left it up to manufacturers to decide whether to list materials in the device on the labeling.4 FDA’s proposed new framework contemplates requiring the labeling of long-term medical devices—those intended to be in contact with the patient for 30 days or more—to identify all constituent materials that might reasonably be expected to come into contact with human tissue. These materials include, for example: metals, polymers, ceramics, naturally derived animal products, naturally derived non-animal products, composites, and manufacturing residuals. FDA proposes naming conventions that would include elemental or chemical names (rather than abbreviations), trade names, animal species and tissue type, plant or bacterial source and material type, and color additives according to the naming conventions used in food and cosmetic labeling. These conventions are intended to “promote transparency and reader comprehension.”5 Additionally, FDA proposes adding specific information about toxicological risks of component materials to medical device labeling.6 FDA describes “toxicological risks” as impurities or residuals that are either known or identified during non-clinical evaluation. In this respect, the discussion paper contemplates that such labeling would not only be beneficial for long-term medical devices, but could also be helpful for labeling of over-the-counter products and short-term devices where small materials changes could significantly impact safety and effectiveness. Finally, FDA is considering requiring manufacturers to include patient labeling (i.e., labeling targeted to the patient or lay caregiver such as patient brochures or implant cards), which is not currently required for all long-term medical devices. Patient labeling would include a basic description of the device and a listing of patient-contacting materials. According to FDA, the primary purpose of identifying component materials in medical device labeling would be “to improve informed decision-making through transparency about materials in such devices to which an individual may have had or could develop an immunological response resulting in adverse health consequences.”7 At the same time, FDA is striving to “balance mitigation of risks with least burdensome principles.”
