FDAVoice: Providing Timely Patient Access to High-Quality, Safe and Effective Medical Devices

Jeffrey Shuren, M.D., J.D. We know that patients with life-threatening or irreversibly debilitating conditions lack treatment and diagnostic options. For these patients, earlier access to promising new devices is critically important. At the same time, delayed access may mean the difference between life and death, or may result in irreversible disability. In weighing the benefits…

Expedited Access Pathway Program

The Expedited Access Pathway (EAP) program is a voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA) or are eligible for de novo requests. The program is detailed in the FDA’s guidance…

Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions

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Agenda posted for April 17, 2015 Neurological Devices Panel of the Medical Devices Advisory Committee

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Consumer Information on: Medtronic CoreValve System

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: Medtronic CoreValve SystemPMA Applicant: Medtronic…

Consumer Information on: WATCHMAN LAA Closure Technology

This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: WATCHMAN LAA Closure TechnologyPMA Applicant:…