Natural rubber-containing medical devices; user labelling--FDA. Final rule; interpretation.
The Food and Drug Administration (FDA) is providing notice that it does not intend to apply to combination products currently regulated under human drug or biologic labeling provisions its September 30, 1997, final rule requiring certain labeling statements for all medical devices that contain or have packaging that contains natural rubber that contacts humans. FDA is taking this action, in part, in response to a citizen petition and other communications from industry that the agency has received since the publication of the final rule. FDA intends to initiate a proceeding to propose natural rubber labeling requirements for drugs and biologics, including combination products that are currently regulated under drug and biologic labeling provisions. Such a proceeding may include a combination of rulemaking and guidance and will offer opportunity for public comment.
D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D018795:Device Approval / Q000331:legislation & jurisprudence*; D006801:Humans; D007840:Latex / Q000009:adverse effects*; D011356:Product Labeling / Q000331:legislation & jurisprudence*; D012408:Rubber / Q000009:adverse effects*; D014481:United States; D014486:United States Food and Drug Administration