Medical Device Reform Act of 1996

[AI summary unavailable — showing source text] 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 acc…