federal_register: 00-1409

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
00-1409 Approval of an Alternate Requirement of the User Labeling Requirements for Devices Containing Dry Natural Rubber that Contact Humans; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Approval of an Alternative Requirement of the User Labeling Requirements for Devices that Contain Dry Natural Rubber that Contact Humans." FDA granted a petition submitted by the Health Industry Manufacturers Association (HIMA), on behalf of in vitro diagnostic device (IVD) manufacturers, that requested a variance from placing the warning statement about dry natural rubber on the immediate IVD package (vial) label. FDA is announcing the availability of its response to HIMA's petition in order to inform affected manufacturers and the public. 2000-01-21 2000 1 https://www.federalregister.gov/documents/2000/01/21/00-1409/approval-of-an-alternate-requirement-of-the-user-labeling-requirements-for-devices-containing-dry https://www.govinfo.gov/content/pkg/FR-2000-01-21/pdf/00-1409.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Approval of an Alternative Requirement of the User Labeling Requirements for Devices that Contain Dry Natural Rubber that Contact Humans." FDA granted a...

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