Medical Device Regulatory Modernization Act of 1997

Summary

Medical Device Regulatory Modernization Act of 1997 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to set forth the Food and Drug Administration (FDA) mission and to mandate annual FDA and Comptroller General reports to specified congressional committees. (Sec. 3) Directs the Secretary of Health and Human Services, when there is a scientific controversy between a regulated person and the Secretary, to establish a procedure under which the regulated person may request a review of the disputed subject matter. (Sec. 4) Revises or imposes requirements regarding: (1) investigational device exemptions; (2) premarket approval requirements (mandating a device review priority); (3) humanitarian device exceptions; (4) safety and effectiveness performance standards (allowing recognition of self-certifiable consensus standards); (5) effectiveness determinations (as used in classifying devices); (6) reliance on postmarket controls to expedite classification; (7) substantial equivalence; (8) labeling (as affecting premarket approval); (9) supplemental applications; (10) promotional material representations; (11) premarket notification; (12) initial classification; (13) classification panels; and (14) premarket approval application review (allowing review by accredited persons). (Sec. 12) Mandates accreditation of persons to review and initially classify devices. (Sec. 13) Mandates publication of a list of types of class III devices that are not subject to regulation under specified provisions and for which the Secretary has determined that premarket approval is unnecessary, requiring each to be regulated as class III subject to general and appropriate special controls. (Sec. 14) Modifies requirements regarding: (1) device tracking; (2) postmarket surveillance; and (3) good manufacturing practice regulations (including foreign harmonization) and inspections (including adding references to accredited entities and post-inspection procedural requirements). (Sec. 17) Removes distributors from recordkeeping and reporting requirements. Removes reporting requirements regarding certain certification and removals and corrections. Mandates new user reporting regulations limiting user reporting to a user subset to create a representative profile of user reports. (Sec. 18) Prohibits subjecting a person to penalties if the person acted in good faith and had no reason to believe the acts violated the law. (Sec. 19) Mandates an information system to track the status of each submission requesting FDA action. (Sec. 20) Prohibits actions by the Secretary of Health and Human Services under the FDCA from requiring the preparation of an environmental assessment or impact statement. (Sec. 22) Regulates communications to non-FDA persons regarding certain matters before completion of related investigations.

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Documents

6 official files

• Reported in House (text)

  Reported in House · EN · 6 October 1997

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• Reported in House (PDF)

  Reported in House · EN · 6 October 1997

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• Reported to House with amendment(s)

  summary · EN · 6 October 1997

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• Introduced in House (text)

  Introduced in House · EN · 22 May 1997

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• Introduced in House (PDF)

  Introduced in House · EN · 22 May 1997

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• Introduced in House

  summary · EN · 22 May 1997

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