Medical devices; device tracking--FDA. Final rule; notification of status under the Safe Medical Devices Act; confirmation of effective date.
The Food and Drug Administration (FDA) is issuing a final rule to establish a device tracking requirement for certain categories of medical devices as required by the Safe Medical Devices Act of 1990 (the SMDA). In a proposed rule issued on May 27, 1992, and published elsewhere in this issue of the Federal Register, FDA discussed the agency's initial review of certain comments received in response to an earlier proposed rule that published in the Federal Register of March 27, 1992 (57 FR 10702), that has been withdrawn. In issuing this final rule, FDA is providing notice that the proposed rule published elsewhere in this issue of the Federal Register now has the status of a final rule by operation of section 3(c)(2) of the SMDA. FDA is also confirming that the effective date of this rule is March 1, 1993. This rule applies to all devices subject to tracking under the SMDA that are initially introduced into interstate commerce or presented for importation into the United States on or after March 1, 1993. In the proposed rule published elsewhere in this issue of the Federal Register, FDA requests comments on that proposal. Upon closure of the comment period for that proposed rule and consideration of comments responding to both the original March 27, 1992, proposed rule and the new proposed rule, FDA will, if necessary, take further actions to revise the rule.
D004282:Documentation / Q000592:standards; D004869:Equipment Safety / Q000592:standards*; D007221:Industry / Q000331:legislation & jurisprudence*; D015918:Infusion Pumps, Implantable / Q000592:standards; D010344:Patient Advocacy / Q000331:legislation & jurisprudence; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards*; D019736:Prostheses and Implants / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration; D012122:Ventilators, Mechanical / Q000592:standards