Submissions for devices that directly contact the body—for example, gloves and condoms—must include a description of the characteristics of their materials. This description should compare the device to its predicate in sufficient detail to determine biocompatibility, as well as the kind of tests needed to determine biocompatibility. Any material differences between the device to be reviewed and the claimed predicate device must be stated explicitly, but it is just as important to state whether the materials comprising the two devices are identical. Manufacturers need to provide biocompatibility test data for any materials found in the new device that are not present in the predicate device. The data should be in a separate biocompatibility section—a section identified as such— well-organized and complete.
For some devices—such as gloves, condoms, contact lenses, and surgical sutures—the manufacturer should provide an exact identification of all colors in the inks, dyes, markings, radiopaque substances, and other such materials used in the manufacturing process. If the color listed by FDA, is the same as the predicate’s color, and there are no apparent concerns, or if the color was included in the general leaching tests, color typically will not be an issue.