Natural Rubber-Containing Medical Devices; User Labeling; Cold Seal Adhesives Partial Stay

The final rule for user labeling requirements for natural rubber-containing medical devices, 21 CFR 801.437, was published on September 30, 1997, and becomes effective on September 30, 1998. The Food and Drug Administration (FDA) is adding a note to that rule to stay, for 270 days from the effective date, paragraphs (f) and (g) as those final rule requirements relate to device packaging that uses ``cold seal'' adhesives. Labeling changes required by other paragraphs of this final rule must be incorporated in the labeling of devices distributed after September 30, 1998, even if the devices are packaged in ``cold seal'' packages. Device packaging that uses natural rubber only on adhesives contained in the flaps of device packaging is not considered subject to the rule. Manufacturers of devices packaged with ``cold seal'' adhesives may, if necessary, submit a petition for an extension of the 270-day stay.