A strategy for integrating regulatory, reimbursement and outcomes research functions for effective market introduction of medical devices in the USA / DFAIT - 1999 (French, PDF)

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Publisher-reported update

2026-01-20

Archived and Outdated Information: This publication is out of date and should be referenced for research or recordkeeping purposes only. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. You can request an alternate version of our publications by email at Accessibilite-accessibility@international.gc.ca or telephone at 1-800-267-8376. Achieving rapid market penetration and fair pricing for innovative medical technology In today's cost- conscious U.S. healthcare environment neceseitates a strategic approach to product development. While Food & Drug Administration (FDA) approval is adequate to establish product safety, healthcare coverage decisions made by payera such as Health Care Finance Administration (HCFA) or managed care plans are increasingly based on evidence of clinical effectiveness and improved patient outcome not to mention value and cost of delivery.

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