Medical Device Regulatory Modernization Act of 1997

[AI summary unavailable — showing source text] 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 p…