[Federal Register Volume 63, Number 168 (Monday, August 31, 1998)]
[Rules and Regulations]
[Pages 46174-46175]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23303]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. 96N-0119]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: 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

[[Page 46175]]

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.

DATES: Effective September 30, 1998, until June 27, 1999.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: John J. Farnham, Center for Devices 
and Radiological Health (HFZ-332), Food and Drug Administration, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-4616.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 30, 
1997 (62 FR 51021), FDA issued a final rule requiring labeling 
statements on medical devices, including device packaging containing 
natural rubber that contacts humans. The rule becomes effective on 
September 30, 1998. On June 5, 1998, the Health Industry Manufacturers 
Association (HIMA) filed a citizen petition requesting FDA to stay 
implementation of the final rule as it pertains to adhesives used in 
packaging, and packaging in general, of medical devices. On June 19, 
1998, FDA denied the HIMA petition with respect to packaging in general 
but stated FDA would grant a stay of the effective date of paragraphs 
(f) and (g) of Sec. 801.437 for 270 days from the effective date of the 
final rule as it pertains to device packaging that uses ``cold seal'' 
adhesives. Labeling changes required by other paragraphs of the final 
rule, such as elimination of the word ``hypoallergenic'' and inclusion 
of the latex content statement for devices that have natural rubber in 
places other than the packaging must be incorporated into the labeling 
of devices distributed after September 30, 1998, even if those devices 
are packaged in ``cold seal'' packages. The agency's response to HIMA's 
petition also clarified that FDA does not consider device packaging 
that uses natural rubber only on adhesives contained in the flaps of 
device packaging to be subject to the rule because such adhesives are 
not intended and are not likely to contact humans. The petition from 
HIMA and the agency's response are available for public examination in 
the Dockets Management Branch (address above) between 9 a.m. and 4 
p.m., Monday through Friday. The agency's response is also available on 
the FDA home page at http://www.fda.gov/cdrh.
    This action is being taken under FDA's authority under 21 CFR 
10.35(a). The Commissioner finds that this stay is in the public 
interest.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
part 801 is amended as follows:

PART 801--LABELING

     1. The authority citation for 21 CFR part 801 continues to read as 
follows:
    Authority: 21 U.S.C. 321, 331, 351, 352, 357, 360i, 360j, 371, 
374.

     2. Section 801.437 is amended by adding the following note to the 
end of the section:


Sec. 801.437  User labeling for devices that contain natural rubber.

*        *        *        *        *
    Note to Sec. 801.437: Paragraphs (f) and (g) are stayed until 
June 27, 1999, as those regulations relate to device packaging that 
uses ``cold seal'' adhesives.

    Dated: August 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-23303 Filed 8-28-98; 8:45 am]
BILLING CODE 4160-01-F