United States Government Printing Office printer prt distributor dst United States National Archives and Records Administration Federal Register Office author aut Government Organization text government publication eng FR Regulatory Information 1998_register executive 2010-09-24 article Rules and Regulations D09002ee180a781d6 D09002ee180a78255 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 63 FR 46174 http://www.gpo.gov/fdsys/granule/FR-1998-08-31/98-23303 98-23303 fr31au98-10 4160-01-F Docket No. 96N-0119 http://www.gpo.gov/fdsys/granule/FR-1998-08-31/98-23303/content-detail.html http://www.gpo.gov/fdsys/pkg/FR-1998-08-31/html/98-23303.htm http://www.gpo.gov/fdsys/pkg/FR-1998-08-31/pdf/98-23303.pdf 2 p. 46174 46175 63 FR 46174 Title 21 Part 801 21 CFR Part 801 Natural Rubber-Containing Medical Devices; User Labeling; Cold Seal Adhesives Partial Stay; Federal Register Vol. 63, Issue RULE 98-23303 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 1998-09-30 Docket No. 96N-0119 4160-01-F 98-23303 Final rule.

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.

Effective September 30, 1998, until June 27, 1999. John J. Farnham, Center for Devices and Radiological Health (HFZ-332), Food and Drug Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-4616. Vol. 63, no. 168 Office of the Federal Register, National Archives and Records Administration 1998-08-31 continuing daily deposited born digital 238 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 http://www.gpo.gov/fdsys/pkg/FR-1998-08-31 P0b002ee180a78186 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr31au98 http://www.gpo.gov/fdsys/pkg/FR-1998-08-31/content-detail.html http://www.gpo.gov/fdsys/pkg/FR-1998-08-31/pdf/FR-1998-08-31.pdf fdlp 46157 46383 DGPO 2010-07-15 2010-07-15 FR-1998-08-31 machine generated eng FR FR-1998-08-31 63 168