Medical devices; reconditioners, rebuilders of medical devices; revocation of compliance policy guide; request for comments--FDA. Notice.
The Food and Drug Administration (FDA) is revoking Compliance Policy Guide (CPG) 7124.28 because application of current good manufacturing practice (CGMP) requirements to "reconditioners/rebuilders" of used medical devices does not comport with definitions in the quality system (QS) regulation or guidance in the final rule that applies CGMP requirements to "manufacturers" and "remanufacturers." Because "reconditioners/rebuilders" are specifically excluded from the definition of "manufacturer" or "remanufacturer" in the QS regulation, guidance in the CPG on the applicability of registration, listing, and other statutory and regulatory requirements to "reconditioners/rebuilders" does not represent current agency thinking. In the advance notice of proposed rulemaking (ANPRM), published in the December 23, 1997, Federal Register, FDA announced its intention to consider identifying the used device market, for regulatory purposes, in terms of "refurbishers," "as-is remarketers," and "servicers" whose activities do not significantly change the safety, performance, or use of a device, and to examine alternative approaches for regulating these firms. Pending the issuance of a rule or guidance setting forth FDA's current position, CPG 7124.28 is being revoked to eliminate obsolete guidance and reduce industry burdens.
D003247:Conservation of Natural Resources / Q000331:legislation & jurisprudence; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D017743:Equipment Reuse / Q000331:legislation & jurisprudence / Q000592:standards*; D019983:Guideline Adherence / Q000331:legislation & jurisprudence*; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence* / Q000592:standards; D011640:Public Policy; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration