Medical devices; substantial equivalence; 510(K) summaries and 510(K) statements; class III summaries; confidentiality of information--FDA. Final rule.
The Food and Drug Administration (FDA) is issuing this final rule to implement the provisions of the Safe Medical Devices Act of 1990 (the SMDA) that require all persons who submit a premarket notification (510(k)) to provide to FDA, as part of the submission, an adequate summary (510(k) summary) of any information respecting safety and effectiveness or a statement (510(k) statement) that such information will be made available upon request by any person. This rule also implements the requirement of the SMDA that 510(k) submitters claiming substantial equivalence to a class III preamendments device for which FDA has not yet called for premarket approval submit a class III summary and certify that they have conducted a search of safety and effectiveness data. In addition, this rule amends the device regulations governing the confidentiality of certain premarket notification submissions to conform to the SMDA. This rule also provides that persons who submit a premarket notification must certify that, to the best of their knowledge, all information is truthful and accurate and that no material fact has been omitted.
D003219:Confidentiality; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004282:Documentation / Q000592:standards; D004869:Equipment Safety / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration