Bill summaries are authored by CRS.

Shown Here:
Reported to House amended (10/06/1997)

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 an annual FDA report to specified congressional committees.

(Sec. 3) Directs the Secretary of Health and Human Services, when there is a scientific controversy between a sponsor, applicant, or manufacturer and the Secretary regarding an FDCA obligation and no specific FDCA provision or regulation provides a right of review, to establish by regulation a procedure under which that party may request a review of the controversy by an appropriate scientific advisory panel.

(Sec. 4) Revises or imposes requirements regarding: (1) investigational device exemptions; (2) expanded access procedures permitting the use of a device for the diagnosis, monitoring, or treatment of conditions that are life-threatening or could be irreversibly debilitating; (3) premarket approval requirements (mandating a device review priority); (4) humanitarian device exceptions; (5) safety and effectiveness device standards (allowing recognition of self-certifiable standards); (6) effectiveness determinations (as used in classifying devices); (7) reliance on postmarket controls to expedite classification; (8) substantial equivalence; (9) labeling (as affecting premarket approval); (10) supplemental applications; (11) premarket notification; (12) initial classification; (13) classification panels; and (14) premarket approval application review.

(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 reclassified into class II or class I.

(Sec. 14) Modifies requirements regarding: (1) device tracking; (2) postmarket surveillance; and (3) good manufacturing practice regulations (including foreign harmonization) and inspections.

(Sec. 17) Modifies recordkeeping and reporting requirements applicable to distributors. Removes reporting requirements regarding annual report filing certifications. Removes references to distributors from provisions relating to removals and corrections. Exempts wholesale distributors who do not manufacture, repackage, process, or relabel a device from provisions requiring annual registration of producers of drugs or devices. Modifies device user facility reporting requirements. Requires, for such facilities that are hospitals or nursing homes, user reporting regulations limiting user reporting to a user subset that constitutes a representative profile of user reports.

(Sec. 18) Mandates an applicant-accessible information system to track the status of each device submission requesting agency action.

(Sec. 20) Prohibits considering a computer software product a device solely because its primary use is related to the provision of health care.

(Sec. 21) Removes from the list of prohibited acts provisions prohibiting, on a drug's or device's labeling or advertising, any suggestion that approval of an application is in effect under, or that the drug or device complies with, specified FDCA provisions.

(Sec. 22) Expresses the sense of the Congress that the availability of a safe, effective, noninvasive glucose meter would greatly enhance the health and well-being of all people with diabetes.