H.R.3201 - Medical Device Reform Act of 1996104th Congress (1995-1996)
Summary: H.R.3201 — 104th Congress (1995-1996)All Bill Information (Except Text)
Introduced in House (03/29/1996)
Medical Device Reform Act of 1996 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to set forth the Food and Drug Administration (FDA) mission.
(Sec. 3) Allows device approval applicants to declare a review impasse and mandates use of a dispute resolution process.
(Sec. 4) Revises requirements regarding: (1) investigational devise exemptions; (2) premarket approval requirements (mandating a device review priority); (3) humanitarian device exceptions; (4) safety and effectiveness performance standards (allowing consensus standards recognition); (5) effectiveness determinations (as used in classifying devices); (6) premarket notification; (7) classification panels; and (8) premarket approval application review (allowing review by accredited persons).
(Sec. 12) Mandates procedures for accrediting parties that review premarket approval applications and conduct good manufacturing practice inspections.
(Sec. 13) Mandates reclassification of certain devices.
(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. 18) Regulates the effect of the dissemination of medical texts, peer-reviewed scientific publications, displays at trade shows, and other material.
(Sec. 19) Removes distributors from record keeping and reporting requirements. Declares that the failure of a device to perform as labeled or in an acceptable manner does not constitute a malfunction when caused by improper servicing. Repeals user reporting requirements.
(Sec. 20) 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. 21) Allows using monetary penalties for violation correction. Entitles violators to reasonable discovery.
(Sec. 22) Mandates an information system to track the status of each submission requesting FDA action.
(Sec. 23) Prohibits actions by the Secretary of Health and Human Services under the FDCA from requiring the preparation of an environmental impact statement or assessment.
(Sec. 24) Prohibits the Secretary from relying on any statements not promulgated in accordance with rulemaking requirements to require any action under the FDCA.
(Sec. 25) Mandates training programs for FDA employees regarding FDCA regulations and policies. Allows the FDA to conduct or contract for scientific research only if directly related to FDCA implementation.
(Sec. 26) Regulates communications to non-FDA persons regarding certain matters before completion of related investigations.