Medical Technology, Public Health, and Innovation Act of 1997

Summary

Medical Technology, Public Health, and Innovation Act of 1997 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to authorize the Secretary of Health and Human Services to identify and list nationally and internationally recognized performance standards for which persons may self-certify a device's conformity in order to meet FDCA requirements. Allows use of data other than that required by the standards to meet any FDCA requirement. Adds to the list of prohibited acts certification falsification or the failure or refusal to provide the data or information relied on in the certification. (Sec. 4) Requires that premarket approval applications include an identifying reference to any such performance standard. Directs the Secretary to accept historical clinical data as a control for use in determining safety and effectiveness when a disease's progression is clearly defined and well understood. Limits requiring clinical trials using randomized controls. Modifies requirements regarding action on premarket approval applications. (Sec. 5) Exempts from premarket notification requirements certain class I and class II devices. Directs the Secretary to develop and publish a list of each type of class II device not requiring premarket notification. Allows petitioning for exemption of a class II type from the notification requirement. (Sec. 6) Changes clinical study approval procedures, allowing: (1) the investigation sponsor to meet with the Secretary before application submission to develop a protocol; and (2) device developmental changes during an investigation without requiring an additional approval or an application supplement, if certain requirements are met. (Sec. 7) Allows device effectiveness to be determined on the basis of one or more clinical investigations (currently, by well-controlled investigations). Requires the Secretary: (1) to consider the extent to which postmarket controls may contribute to the assurance of effectiveness and expedite effectiveness determinations without increasing regulatory burdens; (2) on request, to meet with an intended applicant to determine the type of effectiveness evidence that will be necessary; (3) to consider the extent to which postmarket controls may expedite device classification; (4) when requesting information demonstrating substantial equivalence, to only request information necessary to make substantial equivalence determinations; and (5) base substantial equivalence determinations on the intended uses in submitted labeling.

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3 official files

• Introduced in Senate (text)

  Introduced in Senate · EN · 10 June 1997

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• Introduced in Senate (PDF)

  Introduced in Senate · EN · 10 June 1997

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• Introduced in Senate

  summary · EN · 10 June 1997

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