If the device is to be marketed as part of a convenience kit, the FDA guidance regarding kits should be consulted.1 28 A critical part of that guidance calls for certification by the applicant that the components of the kits have already cleared FDA. If the sterile kit contains finished sterile examination gloves, the notification must contain data to demonstrate that the gloves meet the appropriate American Society for Testing and Materials (ASTM) standards, or their equivalent, and that they pass FDA’s 1000-ml water leak test. The gloves must also pass the leak test after undergoing accelerated aging according to one of the protocols described by ASTM, or their equivalent.
If the kit contains sutures, the manufacturer should provide evidence that the sterilant does not contact the sutures during the sterilization process. Some kit assemblers package sutures separately, adding them into the main tray only after it has been processed and sterilized. If sutures are included as part of the kit, the manufacturer cannot change their labeling, packaging, or method of sterilization without prior notification, review, and approval by FDA. Similarly, the supplier of the sutures included in the kit cannot be changed without prior notification, review, and approval by FDA.
If the device kit contains items that are subject to regulation as drugs, a substantially equivalent determination by CDRH will not apply to the drugs in the kit. For information on applicable FDA requirements for marketing drugs in a kit, contact the Center for Drug Evaluation and Research.