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Medical Devices and the Approval Processes: United States vs France

Medical Devices and the Approval Processes: United States vs France Redberg rightly supported the plans for the new approval process from the US Food and Drug Administration (FDA) for medical devices.1 The FDA has announced it will significantly strengthen its premarket clearance process (which is under review by the Institute of Medicine) and the process for developing and reviewing postmarket data.1 The FDA also has announced a new transparency initiative requiring that clinical data be publicly available. Indeed, a prudent policy is warranted before approval: high-quality clinical data must show that the benefits outweigh the risks. Sadly, the ASTRAL (Angioplasty and Stent for Renal Artery Lesions) trial will not be the last one to remind us that evidence is more important than hope.2 The practice of dilatating and stenting renal arteries has spread like an epidemic since the 1980s (eg, 45 000 per year in the United States).3 In 2009, ASTRAL showed no benefit from these vascular procedures vs drug treatment but only serious complications (23 per 400 patients, including 2 deaths and 3 amputations). In the 1980s, FDA standards for medical devices were deficient.3 By contrast, the French drug agency (Agence Française de Sécurité Sanitaire des Produits de Santé [AFSSAPS]) has recently developed an opposite concept. The chief executive officer of AFSSAPS has just prefaced a book on medical devices, which is freely offered by Medtronic. One of the authors is Medtronic's director of regulatory affairs, and the other one is the director in charge of medical devices evaluation at AFSSAPS. The chapter on evaluation is a pledge to avoid evaluation: “rapid obsolescene of the products . . . is hardly compatible with the delay necessary for clinical trials, particularly morbidity-mortality data.”4(p57) The alternative solution recommended is “predictive equivalence”!4 No one seems to know what can be considered “predictive equivalence” but the authors. A two-dozen–lined chapter titled “Predicitive Appearance of Pre-clinical Evaluation” indicated that clinical evaluation can be limited to the check of the results of the specific test bench. There is no concern for clinical end points such as mortality and morbidity, effectiveness, and the collection of postapproval data. Correspondence: Dr Braillon, 27 rue Voiture, 80000 Amiens, France (braillon.alain@gmail.com). References 1. Redberg RF Medical devices and the FDA approval process: balancing safety and innovation [published online August 9, 2010]. Arch Intern Med 2010;PubMed10.1001/archinternmed.2010.323Google Scholar 2. Wheatley KIves NGray R et al. ASTRAL Investigators, Revascularization versus medical therapy for renal-artery stenosis. N Engl J Med 2009;361 (20) 1953- 1962PubMedGoogle Scholar 3. FDA standards for medical devices. Arch Intern Med 1980;140 (5) 602Google Scholar 4. Audry AGhislain JC Le Dispositif Médical. Paris, France Presses Universitaires de France2009;55- 57 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Internal Medicine American Medical Association

Medical Devices and the Approval Processes: United States vs France

Archives of Internal Medicine , Volume 170 (22) – Dec 13, 2010

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Publisher
American Medical Association
Copyright
Copyright © 2010 American Medical Association. All Rights Reserved.
ISSN
0003-9926
eISSN
1538-3679
DOI
10.1001/archinternmed.2010.454
Publisher site
See Article on Publisher Site

Abstract

Redberg rightly supported the plans for the new approval process from the US Food and Drug Administration (FDA) for medical devices.1 The FDA has announced it will significantly strengthen its premarket clearance process (which is under review by the Institute of Medicine) and the process for developing and reviewing postmarket data.1 The FDA also has announced a new transparency initiative requiring that clinical data be publicly available. Indeed, a prudent policy is warranted before approval: high-quality clinical data must show that the benefits outweigh the risks. Sadly, the ASTRAL (Angioplasty and Stent for Renal Artery Lesions) trial will not be the last one to remind us that evidence is more important than hope.2 The practice of dilatating and stenting renal arteries has spread like an epidemic since the 1980s (eg, 45 000 per year in the United States).3 In 2009, ASTRAL showed no benefit from these vascular procedures vs drug treatment but only serious complications (23 per 400 patients, including 2 deaths and 3 amputations). In the 1980s, FDA standards for medical devices were deficient.3 By contrast, the French drug agency (Agence Française de Sécurité Sanitaire des Produits de Santé [AFSSAPS]) has recently developed an opposite concept. The chief executive officer of AFSSAPS has just prefaced a book on medical devices, which is freely offered by Medtronic. One of the authors is Medtronic's director of regulatory affairs, and the other one is the director in charge of medical devices evaluation at AFSSAPS. The chapter on evaluation is a pledge to avoid evaluation: “rapid obsolescene of the products . . . is hardly compatible with the delay necessary for clinical trials, particularly morbidity-mortality data.”4(p57) The alternative solution recommended is “predictive equivalence”!4 No one seems to know what can be considered “predictive equivalence” but the authors. A two-dozen–lined chapter titled “Predicitive Appearance of Pre-clinical Evaluation” indicated that clinical evaluation can be limited to the check of the results of the specific test bench. There is no concern for clinical end points such as mortality and morbidity, effectiveness, and the collection of postapproval data. Correspondence: Dr Braillon, 27 rue Voiture, 80000 Amiens, France (braillon.alain@gmail.com). References 1. Redberg RF Medical devices and the FDA approval process: balancing safety and innovation [published online August 9, 2010]. Arch Intern Med 2010;PubMed10.1001/archinternmed.2010.323Google Scholar 2. Wheatley KIves NGray R et al. ASTRAL Investigators, Revascularization versus medical therapy for renal-artery stenosis. N Engl J Med 2009;361 (20) 1953- 1962PubMedGoogle Scholar 3. FDA standards for medical devices. Arch Intern Med 1980;140 (5) 602Google Scholar 4. Audry AGhislain JC Le Dispositif Médical. Paris, France Presses Universitaires de France2009;55- 57

Journal

Archives of Internal MedicineAmerican Medical Association

Published: Dec 13, 2010

Keywords: medical devices

References