[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