PubMed · 5552491
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V K Dave. 1971-04-29. Contact dermatitis.. https://pubmed.ncbi.nlm.nih.gov/5552491/
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The Food and Drug Administration (FDA) is issuing an amended economic analysis statement relating to a final rule that published in the Federal Register of September 30, 1997 (62 FR 51021), requiring labeling statements concerning the presence of natural rubber latex in medical devices. This rule was issued in response to numerous reports of severe allergic reactions and deaths related to a wide range of medical devices containing natural rubber. The final rule becomes effective on September 30, 1998. In order to allow further comment on the economic impact of the September 30, 1997, final rule, FDA published in the Federal Register of June 1, 1998, an amended economic impact statement, including an amended initial regulatory flexibility analysis (IRFA) that it prepared under the Regulatory Flexibility Act (RFA), as amended by the small Business Regulatory Enforcement and Fairness Act (SBREFA). After considering comments submitted in response to the June 1, 1998, amended economic analysis statement, FDA is issuing the amended final economic impact statement, including an amended final regulatory flexibility analysis.
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.