device approval

Summary

Summary: Process that is gone through in order for a device to receive approval by a government regulatory agency. This includes any required preclinical or clinical testing, review, submission, and evaluation of the applications and test results, and post-marketing surveillance. It is not restricted to FDA.

Top Publications

  1. ncbi Successful recruitment for medical device clinical studies
    Maria Donawa
    Donawa and Associates Ltd, Rome, Italy
    Med Device Technol 15:25-7. 2004
  2. ncbi When to conduct a clinical trial
    J P Boutrand
    Biomatech SAS, a Namsa Company, Chasse sur Rhone, France
    Med Device Technol 15:28-31. 2004
  3. ncbi Who should protect the public? The Supreme Court and medical device regulation
    Russell Korobkin
    UCLA School of Law, Los Angeles, USA
    N Engl J Med 357:1680-1. 2007
  4. ncbi Ensuring safe and effective medical devices
    David W Feigal
    Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD, USA
    N Engl J Med 348:191-2. 2003
  5. ncbi Making sense of the food and drug administration
    Jessica Anne Connor
    Biodesign Surgical Innovation Program, Stanford University, Stanford, California 94305, USA
    Semin Pediatr Surg 15:293-301. 2006
  6. ncbi Medical device regulation: an introduction for the practicing physician
    William H Maisel
    Cardiovascular Division, Brigham and Women s Hospital, Boston, Massachusetts 02115, USA
    Ann Intern Med 140:296-302. 2004
  7. ncbi FDA marketing claims, and the practitioner
    Susan Runner
    Center for Devices and Radiological Health, Office of Device Evaluation, Food and Drug Administration, Rockville, MD, USA
    J Evid Based Dent Pract 6:19-23. 2006
  8. ncbi Evaluation of diagnostic imaging technologies and therapeutics devices: better information for better decisions: proceedings of a multidisciplinary workshop
    Robert M Califf
    Duke Clinical Research Institute, Durham, NC 27715, USA
    Am Heart J 152:50-8. 2006
  9. ncbi Unanswered questions--drug-eluting stents and the risk of late thrombosis
    William H Maisel
    Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, USA
    N Engl J Med 356:981-4. 2007
  10. ncbi Stent thrombosis redux--the FDA perspective
    Andrew Farb
    Interventional Cardiology Devices Branch, of the Office of Device Evaluation, Center for Devices and Radiological Health, FDA, Rockville, USA
    N Engl J Med 356:984-7. 2007

Research Grants

Detail Information

Publications199 found, 100 shown here

  1. ncbi Successful recruitment for medical device clinical studies
    Maria Donawa
    Donawa and Associates Ltd, Rome, Italy
    Med Device Technol 15:25-7. 2004
    ..This article discusses the importance of devising an effective subject recruitment strategy so that clinical and regulatory requirements can be met...
  2. ncbi When to conduct a clinical trial
    J P Boutrand
    Biomatech SAS, a Namsa Company, Chasse sur Rhone, France
    Med Device Technol 15:28-31. 2004
    ..Clinical evidence can also be based on systematic and objective literature review. This article highlights when to use the clinical or the literature route to demonstrate the safety and performance of a medical device...
  3. ncbi Who should protect the public? The Supreme Court and medical device regulation
    Russell Korobkin
    UCLA School of Law, Los Angeles, USA
    N Engl J Med 357:1680-1. 2007
  4. ncbi Ensuring safe and effective medical devices
    David W Feigal
    Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD, USA
    N Engl J Med 348:191-2. 2003
  5. ncbi Making sense of the food and drug administration
    Jessica Anne Connor
    Biodesign Surgical Innovation Program, Stanford University, Stanford, California 94305, USA
    Semin Pediatr Surg 15:293-301. 2006
    ....
  6. ncbi Medical device regulation: an introduction for the practicing physician
    William H Maisel
    Cardiovascular Division, Brigham and Women s Hospital, Boston, Massachusetts 02115, USA
    Ann Intern Med 140:296-302. 2004
    ..Physicians should understand the rules that govern the approved and unapproved use of medical devices as well as device premarket evaluation and approval processes and device postmarket surveillance...
  7. ncbi FDA marketing claims, and the practitioner
    Susan Runner
    Center for Devices and Radiological Health, Office of Device Evaluation, Food and Drug Administration, Rockville, MD, USA
    J Evid Based Dent Pract 6:19-23. 2006
    ....
  8. ncbi Evaluation of diagnostic imaging technologies and therapeutics devices: better information for better decisions: proceedings of a multidisciplinary workshop
    Robert M Califf
    Duke Clinical Research Institute, Durham, NC 27715, USA
    Am Heart J 152:50-8. 2006
    ....
  9. ncbi Unanswered questions--drug-eluting stents and the risk of late thrombosis
    William H Maisel
    Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, USA
    N Engl J Med 356:981-4. 2007
  10. ncbi Stent thrombosis redux--the FDA perspective
    Andrew Farb
    Interventional Cardiology Devices Branch, of the Office of Device Evaluation, Center for Devices and Radiological Health, FDA, Rockville, USA
    N Engl J Med 356:984-7. 2007
  11. ncbi Challenges in regulating breakthrough medical devices
    Neal I Muni
    Center for Devices and Radiological Health CDRH, U S Food and Drug Administration FDA, Rockville, MD, USA
    Food Drug Law J 60:137-42. 2005
  12. ncbi What the code of federal regulations means to you
    Arthur Yellin
    Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, USA
    Biomed Instrum Technol 39:285-7. 2005
  13. ncbi Medical devices: the obvious, the readily-accepted, and the surprising
    Deborah E Tolomeo
    King and Spalding, LLP, Redwood Shores, California, USA
    J Health Life Sci Law 1:117, 119-44. 2008
    ..This article provides examples of the Agency's interpretation of the statutory definition of a medical device and shows how to analyze whether a product is an FDA-regulated medical device...
  14. ncbi Remarks of the Acting FDA Commissioner: FDLI's 48th annual conference
    Lester M Crawford
    Food and Drug Administration FDA, Rockville, MD, USA
    Food Drug Law J 60:99-102. 2005
  15. ncbi US importer and distributor requirements
    Maria Donawa
    Donawa Consulting
    Med Device Technol 16:25-7. 2005
    ..This article discusses the requirements and actions that nonUS manufacturers should take to ensure these requirements are met...
  16. ncbi The FDA's role in medical device clinical studies of human subjects
    James Saviola
    Vitreoretinal and Extraocular Devices Branch, Division of Ophthalmic and ENT Devices, Office of Device Evaluation, CDRH, FDA, USA
    J Neural Eng 2:S1-4. 2005
    ..The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices...
  17. ncbi Devices and the food and drug administration
    Steven J Phillips
    Artif Organs 29:363-5. 2005
  18. ncbi FDA pilot programme in support of global harmonisation
    Maria E Donawa
    Donawa and Associates Ltd, Via Fonte di Fauno 22, I 00153 Rome, Italy
    Med Device Technol 14:32-4. 2003
    ..This article discusses the programme and why European manufacturers should consider participating...
  19. ncbi An overview of drug development in the United States and current challenges
    Sharon Wyatt Moore
    Medical and Regulatory Affairs, Clinical Trial Management Services, Inc, Bristol, TN 37620, USA
    South Med J 96:1244-55; quiz 1256. 2003
    ..Although the ultimate goal is to bring safer and more effective medical products to patients in a timely manner, multiple challenges face those who participate in drug development...
  20. ncbi Medical device development: from prototype to regulatory approval
    Aaron V Kaplan
    Section of Cardiology, Dartmouth Hitchcock Medical Center, One Medical Center Dr, Lebanon, NH 03756 0001, USA
    Circulation 109:3068-72. 2004
  21. ncbi Regulatory issues for computerized electrocardiographic devices
    Neal I Muni
    Department of Health and Human Services, Center for Devices and Radiological Health, US Food and Drug Administration, Rockville, MD, USA
    J Electrocardiol 37:74-7. 2004
    ....
  22. ncbi Legal overprotection
    Joseph H Friedman
    Med Health R I 87:294. 2004
  23. ncbi Overview of success of EVAR: progress to date
    G Matthew Longo
    Division of Vascular Surgery, Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, IL 60611, USA
    Semin Vasc Surg 17:307-13. 2004
    ..This review looks at the successes of EVAR, based on both US Food and Drug Administration trials and independent studies comparing conventional open repair and endovascular repair...
  24. ncbi Devices, drugs, and the Food and Drug Administration: increasing implications for ischemic stroke
    Anthony J Furlan
    Department of Neurology, University of Massachusetts Medical School, Worcester, Mass 01605 2982, USA
    Stroke 36:398-9. 2005
  25. ncbi Approval of the MERCI clot retriever: a critical view
    Kyra J Becker
    University of Washington School of Medicine, Harborview Medical Center, Box 359775, 325 9th Ave, Seattle, WA 98104 2499, USA
    Stroke 36:400-3. 2005
  26. pmc Economic implications of potential changes to regulatory and reimbursement policies for medical devices
    Shelby D Reed
    Center for Clinical and Genetic Economics, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715, USA
    J Gen Intern Med 23:50-6. 2008
    ..To evaluate the impact of regulatory scenarios on the financial viability of medical device companies...
  27. ncbi Postmarket evaluation of breakthrough technologies
    Sunil V Rao
    Duke Clinical Research Institute and Duke University Medical Center, Durham, NC 27705, USA
    Am Heart J 156:201-8. 2008
    ....
  28. ncbi In search of a coherent framework: options for FDA oversight of genetic tests
    Gail H Javitt
    Genetics and Public Policy Center, Berman Institute of Bioethics, Georgetown University Law Center, USA
    Food Drug Law J 62:617-52. 2007
  29. ncbi Is that product safe? How to guarantee the integrity of medical supplies and tell staff about recalls
    Lee Ann Runy
    Hosp Health Netw 81:6 p following 46, 2. 2007
    ..And it pays special attention to the ways hospitals can disseminate recall notices out to all affected staff as quickly and thoroughly as possible...
  30. ncbi FDA medical device approval: things you didn't learn in medical school or residency
    Barbara Buch
    Division of General, Restorative, and Neurological Devices, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD 20850, USA
    Am J Orthop (Belle Mead NJ) 36:407-12. 2007
    ..Common myths are set straight, and FDA's concerns with "off-label" use are discussed. The role of the orthopedic surgeon in the regulatory process is also introduced...
  31. ncbi Vioxx, radiology, and the Food and Drug Administration
    Michael J Pentecost
    Department of Radiology, Georgetown University Medical Center, Washington, DC 20007 2197, USA
    J Am Coll Radiol 2:394-7. 2005
  32. pmc Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment
    Mitchell D Feldman
    Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA 94143 0320, USA
    J Gen Intern Med 23:57-63. 2008
    ..However, significant gaps persist in the scientific literature, in the medical device approval process, and in the realm of postmarketing surveillance...
  33. ncbi FDA-regulated validation in clinical and nonclinical environments
    Connie Curts
    IEEE Eng Med Biol Mag 26:91-3, 101. 2007
  34. ncbi Insertion procedure, aftercare, and soft-tissue reaction of the 2.5-mm titanium tube system for a transcutaneous air conduction hearing aid system
    Theo Wesendahl
    ENT Clinic Isselstein Wesendahl, Rheine, Germany
    Int Tinnitus J 12:3-8. 2006
    ..One key objective is to ensure that the soft-tissue channel in which the titanium tube is implanted heals without any inflammatory reaction...
  35. ncbi Strategic planning for U.S. premarket approval submissions
    Maria Donawa
    Donawa Consulting srl, Rome, Italy
    Med Device Technol 17:21-3. 2006
    ..This article discusses the importance of strategic planning for submission of a PMA and the issues that should be considered, which can lead to a reduction in the time and cost involved...
  36. ncbi Progress versus precision: challenges in clinical trial design for left ventricular assist devices
    Michael K Parides
    International Center for Health Outcomes and Innovation Research, Columbia University, New York, New York 10032, USA
    Ann Thorac Surg 82:1140-6. 2006
    ..We also advocate an evidence shift toward postmarketing studies, with the Interagency Registry of Mechanically Assisted Circulatory Support providing a robust infrastructure...
  37. ncbi How are drugs approved? Part 1: the evolution of the Food and Drug Administration
    Robert H Howland
    University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, PA 15213, USA
    J Psychosoc Nurs Ment Health Serv 46:15-9. 2008
    ..This will provide background for two subsequent articles in this series, which will describe the ethical foundations of clinical research and hethe stages of drug development...
  38. ncbi Medical devices post-approval studies program: vision, strategies, challenges and opportunities
    Danica Marinac-Dabic
    Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, USA
    Food Drug Law J 62:597-604. 2007
  39. ncbi The Food and Drug Administration's regulation of risk disclosure for implantable cardioverter defibrillators: has technology outpaced the Agency's regulatory framework?
    Edward M Basile
    King and Spaulding L L P, Washington, D C, USA
    Food Drug Law J 61:251-72. 2006
  40. ncbi Old customs, ancient lore: the development of custom device law through neglect
    Robert J Klepinski
    Fredrickson and Byron, P A, Minneapolis, MN, USA
    Food Drug Law J 61:237-49. 2006
  41. ncbi Ethics and the FDA
    John Fielder
    IEEE Eng Med Biol Mag 25:13-7. 2006
  42. ncbi Change, but not in dollar bills. FDA needs more than money to fix problems: Congress
    Jennifer Lubell
    Mod Healthc 38:10-1. 2008
  43. ncbi Working together to enhance the efficiency of medical product development
    Wendy R Sanhai
    U S Food and Drug Administration, Rockville, MD, USA
    J Nucl Med 49:43N-45N. 2008
  44. ncbi The risk of risk reduction: can postmarket surveillance pose more risk than benefit?
    Ralph F Hall
    University of Minnesota Baker and Daniels LLP, Indianapolis, Indiana, and Washington, DC and MR3 Medical, LLC, USA
    Food Drug Law J 62:473-92. 2007
  45. ncbi The U.S. FDA's involvement in the development and utilization of D11.40's standards on rubber consumer products
    Chiu S Lin
    Infection Control Devices Branch, Office of Device Evaluation, Center for Devices and Radiological Health, U S FDA, USA
    Stand News 31:38-41. 2003
  46. ncbi Assessing the safety of the new 30-night contact lenses
    Oliver D Schein
    Dana Center for Preventive Ophthalmology, The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, MD, USA
    Eye Contact Lens 29:S157-9; discussion S166, S192-4. 2003
  47. ncbi Myths and realities in medical packaging
    R Pilchik
    Techmark Group, Cherry Hill, New Jersey, USA
    Med Device Technol 14:16-7. 2003
    ..This round-up of packaging myths provides a reality check on the real world of packaging medical products. Table I shows medical device FDA-assisted recalls due to packaging failures...
  48. ncbi What does it take? A case study of radical change toward patient safety
    Kim J Vicente
    Department of Mechanical and Industrial Engineering, University of Toronto, Toronto, Ontario, Canada
    Jt Comm J Qual Saf 29:598-609. 2003
    ..A medical device manufacturer appeared to initiate this radical shift after exhibiting the traditional approach for years...
  49. ncbi Fighting fire with fire: new test standard benefits medical oxygen regulator designers and users
    Lori Kubinski
    NASA White Sands Test Facility
    Stand News 31:42-5. 2003
  50. ncbi Regulatory aspects of invasive glucose measurements
    Steve Gutman
    Center for Devices and Radiologic Health, Rockville, Maryland 20855, USA
    Diabetes Technol Ther 4:775-7. 2002
    ..To date, noninvasive and minimally invasive glucose testings have been approved through the PMA process and will be discussed in a separate article...
  51. ncbi Managing changes during a clinical investigation, Part I
    Maria Donawa
    Donawa and Associates Ltd, Via Fonte di Fauno 22, I 00153 Rome, Italy
    Med Device Technol 14:31-3. 2003
    ..Part II will discuss European requirements and the need for developing a standard operating procedure to help ensure consistent compliance...
  52. ncbi Food and Drug Administration regulation of orthotic cranioplasty
    T R Littlefield
    Cranial Technologies, 1331 North Seventh Street, Suite 170, Phoenix, AZ 85006, USA
    Cleft Palate Craniofac J 38:337-40. 2001
    ..Submission of a premarket notification (510[k]) is required prior to placing these devices on the market...
  53. ncbi U.S. FDA rules for device investigations
    Robert Munzner
    IEEE Eng Med Biol Mag 22:95-6. 2003
  54. ncbi Ready, aim, fire! New IO device simplifies vascular access in severe cases
    Jeff Lindsey
    Estero Fla Fire Rescue, USA
    JEMS 28:97-8. 2003
  55. ncbi Better health care with quality medical devices: FDA on the cutting edge of device technology
    Suzanne Rich
    Center for Devices and Radiological Health, Office of Surveillance and Biometrics, Food and Drug Administration, Rockville, MD 20850, USA
    Int J Trauma Nurs 8:89-90. 2002
  56. ncbi The Food and Drug Administration should regulate medical devices--not hospitals
    Nathan L Belkin
    Am J Infect Control 31:499-501. 2003
  57. ncbi Scarred lives. A faulty jaw implant was recalled years ago; thousands of patients found out too late
    Dana Hawkins
    US News World Rep 133:60-1. 2002
  58. ncbi The impact of FDA reform
    Janet Trunzo
    AdvaMed, Washington, District of Columbia, USA
    Med Device Technol 14:36-7. 2003
    ..The changes introduced by the Medical Device User Fee and Modernisation Act should ensure a timely and effective review process. The impact of some of the reforms is discussed here...
  59. ncbi Wavefront-guided LASIK for the correction of primary myopia and astigmatism a report by the American Academy of Ophthalmology
    Steven C Schallhorn
    American Academy of Ophthalmology, Quality Care and Knowledge Base Development, P O Box 7424, San Francisco, CA 94120 7424, USA
    Ophthalmology 115:1249-61. 2008
    ..To describe wavefront-guided (WFG) LASIK for the primary treatment of low to moderate levels of myopia and astigmatism and to examine the evidence on the safety and effectiveness of the procedure in comparison with conventional LASIK...
  60. ncbi Regulatory and medical-legal aspects of intraoperative monitoring
    Marc R Nuwer
    Department of Neurology, School of Medicine, University of California at Los Angeles UCLA, California, USA
    J Clin Neurophysiol 19:387-95. 2002
    ..Public policy issues for intraoperative monitoring include billing, coding, reimbursement, staffing, device approval, and liability. Staffing issues include privileging, credentialing, certifying, training, and professionalism...
  61. ncbi Carotid stenting with distal protection in high surgical risk patients: the BEACH trial 30 day results
    Christopher J White
    Department of Cardiology, Ochsner Clinic Foundation, New Orleans, Louisiana 70121, USA
    Catheter Cardiovasc Interv 67:503-12. 2006
    ..The BEACH trial evaluated the outcomes of carotid artery stent placement with distal emboli protection, using the Carotid Wallstent and the FilterWire EX/EZ(TM), in patients at high surgical risk for carotid endarterectomy (CEA)...
  62. ncbi The impact of technology on health care cost and policy development
    Paul E Wallner
    21st Century Oncology, Inc, Fort Myers, FL, USA
    Semin Radiat Oncol 18:194-200. 2008
    ..Our current system of device approval unlinked to coverage and payment has produced further disruption in the system...
  63. ncbi The CAPTURE registry: predictors of outcomes in carotid artery stenting with embolic protection for high surgical risk patients in the early post-approval setting
    William A Gray
    Columbia University Medical Center, 161 Ft Washington Avenue, Fifth Floor, New York, NY 10032, USA
    Catheter Cardiovasc Interv 70:1025-33. 2007
    ..This report examines predictors of outcomes in carotid stenting in the earliest and largest prospective multicenter neurologist-adjudicated experience in the United States post device approval.
  64. ncbi The CAPTURE registry: analysis of strokes resulting from carotid artery stenting in the post approval setting: timing, location, severity, and type
    Ronald Fairman
    Division of Vascular Surgery and Endovascular Therapy, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, USA
    Ann Surg 246:551-6; discussion 556-8. 2007
    ..This report examines the timing, location, severity, and type of strokes occurring with CAS in the Carotid ACCULINK/ACCUNET Post Approval Trial to Uncover Unanticipated or Rare Events (CAPTURE) study...
  65. ncbi Rethinking analytical strategies for surveillance of medical devices: the case of hip arthroplasty
    Sharon Lise Normand
    Department of Health Care Policy, Harvard Medical School, Boston, MA 02115 5821, USA
    Med Care 48:S58-67. 2010
    Randomized trials that sometimes serve as the basis for device approval are small, short term, and generalizable to an increasingly smaller percentage of patients...
  66. ncbi Outcomes of care of abdominal aortic aneurysm in Veterans Health Administration facilities: results from the National Surgical Quality Improvement Program
    Ruth L Bush
    Texas A and M Health Sciences Center, Olin E Teague Veterans Affairs Medical Center, Temple, TX, USA
    Am J Surg 198:S41-8. 2009
    ..Soon after introduction of endovascular aneurysm repair (EVAR), with Food and Drug Administration device approval in 1999, robust electronic NSQIP records immediately began to capture individual facility performances and ..
  67. ncbi Urogynaecological research: current and future developments
    Gunnar Lose
    Department of Obstetrics and Gynecology, Glostrup Municipal Hospital, Ndr Ringvej, 2600, Glostrup, Denmark
    Int Urogynecol J Pelvic Floor Dysfunct 18:599-601. 2007
    The massive introduction of new products from device and drug industries together with a scanty device approval process and a growing scepticism about the reliability of drug trials call for new improved strategies in urogynaecological ..
  68. ncbi Clinical use of sirolimus-eluting stents
    Ajay J Kirtane
    Center for Interventional Vascular Therapy, Columbia University Medical Center, New York, NY 10032, USA
    Cardiovasc Drug Rev 25:316-32. 2007
    ..used outside of the specific patient and lesion subsets studied in the pivotal randomized trials that led to device approval by regulatory bodies within the United States and abroad...
  69. ncbi Development of a micromachined epiretinal vision prosthesis
    Thomas Stieglitz
    Department of Microsystems Engineering IMTEK, Laboratory for Biomedical Microtechnology, University of Freiburg, Georges Koehler Allee 102, 79110 Freiburg, Germany
    J Neural Eng 6:065005. 2009
    ..Research results have been transferred successfully to companies that currently work on the medical device approval of these retinal vision prostheses in Europe and in the USA.
  70. ncbi Review of the Medical Device Directive
    Maria Donawa
    Donawa and Associates Ltd, an Aventor Partner, Via Fonte di Fauno 22, I 00153 Rome, Italy
    Med Device Technol 14:20-3. 2003
    ..This article discusses the official review of the MD Directive, its conclusions, and some of the more important activities resulting from the review...
  71. ncbi Quality assurance for antimicrobial devices
    J Bruenke
    Bio Gate AG, Nuremberg, Germany
    Med Device Technol 17:16-8. 2006
    ..As the market pushes the development of new devices with antimicrobial properties there is rapidly growing interest in antimicrobial testing. QA systems for antimicrobial device testing are discussed here...
  72. ncbi Use of standards in the review of medical devices
    Charles Ho
    Department of Health and Human Services, Center for Devices and Radiological Health, U S Food and Drug Administration, Rockville, MD 20850, USA
    J Electrocardiol 38:171-4. 2005
    ..Specific examples will be presented on medical devices, such as electrocardiogram cables and connectors, and noninvasive blood pressure monitors...
  73. ncbi Modeling for health care and other policy decisions: uses, roles, and validity
    M C Weinstein
    Program on the Economic Evaluation of Medical Technology, Harvard Center for Risk Analysis, Harvard School of Public Health, 718 Huntington Avenue, Boston, MA 02115, USA
    Value Health 4:348-61. 2001
    ..Implications for the implementation of Section 114 of the Food and Drug Administration Modernization Act (FDAMA) are derived from this framework...
  74. ncbi [Preliminary discussion on the preparation of medical device standards adopting international standards]
    Jia Zheng
    National Institutes for Food and Drug Control, Beijing, 100050
    Zhongguo Yi Liao Qi Xie Za Zhi 36:215-7. 2012
    ..Provide relevant suggestion and recommendation in accordance to GB/T 1.1-2009 and GB/T 20000.2-2009, some preliminary suggestions were accordingly proposed...
  75. ncbi European Clinical Trials Directive: responses made to MHRA consultation letter MLX 287
    David J Flavell
    Lancet 362:1415. 2003
  76. doi Setting the standard
    Adarsh Sandhu
    Nat Nanotechnol 3:63-4. 2008
  77. ncbi Medical device innovation: prospective solutions for an ecosystem in crisis. Adding a professional society perspective
    Mitchell W Krucoff
    Duke University Medical Center Duke Clinical Research Institute, 2400 Pratt Street, Durham, NC 27705, USA
    JACC Cardiovasc Interv 5:790-6. 2012
    ..Professional societies are well positioned to convene pre-competitive dialogue, facilitate alignment, and add perspective to equipoise within the innovation ecosystem...
  78. ncbi What is the minimal follow up period to be considered significant when evaluating a valve prosthesis model? Should 'actual' and 'actuarial' curves be considered always essential for any scientific presentation?
    Andrea Sala
    Department of Cardiac Surgery, University of Insubria, Ospedale di Circolo, Varese, Italy
    J Heart Valve Dis 13:S18-9. 2004
  79. ncbi [Development and evaluation of new drugs and medical devices in Japan--standpoint of regulatory agency]
    Hiroshi Maruyama
    Pharmaceuticals and Medical Devices Agency PMDA, 3 3 2 Kasumigaseki, Chiyoda ku, Tokyo 100 0013, Japan
    Brain Nerve 62:263-8. 2010
    ..We strive to promote the regulatory science by establishing communication with external scientists and providing enhanced training to improve the staff's capability to apply regulatory science...
  80. ncbi Drug-eluting stents: caution and concerns for long-term outcome
    Renu Virmani
    Department of Cardiovascular Pathology, Armed Forces Institute of Pathology, Washington, DC, USA
    Coron Artery Dis 15:313-8. 2004
    ..This incidence promotes a cautionary view and perhaps supports the use of DES only in high-risk patients...
  81. ncbi Regulation of health-related technologies in Germany
    M Perleth
    Hannover Medical School, Department of Epidemiology, Social Medicine and Health System Research, Germany
    Health Policy 46:105-26. 1999
    ..This applies also to diffusion and usage of technologies. However, steering of usage of health related technologies is generally weak in Germany since only non-binding guidelines are in place...
  82. ncbi Getting dumped
    Brady Huggett
    Nat Biotechnol 25:841-3. 2007
  83. ncbi Summary of the Food and Drug Administration's Circulatory System Devices Advisory Panel meeting December 7 and 8, 2006, Gaithersburg, MD
    Kathryn C Coons
    Division of Cardiology, Washington Hospital Center, Washington, DC 20010, USA
    Cardiovasc Revasc Med 8:2-4. 2007
  84. pmc Critical appraisal of medical devices in the management of cerebrovascular disease
    Michael J Schneck
    Departments of Neurology and Neurological Surgery, Loyola University Chicago, Stritch School of Medicine Maywood, Illinois, USA
    Ther Clin Risk Manag 4:19-29. 2008
    ..By comparison with pharmaceuticals, the device approval process and subsequent application of these devices in stroke treatment is founded on a paucity of Class I ..
  85. ncbi Effective standards and regulatory tools for respiratory gas monitors and pulse oximeters: the role of the engineer and clinician
    Sandy Weininger
    Office of Science and Engineering Laboratories, Division of Electronics and Software Engineering, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland 20993 0002, USA
    Anesth Analg 105:S95-9, tables of contents. 2007
    ..The discussion is followed by an examination of how engineering and clinical knowledge are used to support the assurance of safety...
  86. ncbi Adaptive clinical trials for new drug applications in Japan
    Yuki Ando
    Office of New Drug II, Pharmaceuticals and Medical Devices Agency, 3 3 2 Kasumigaseki, Chiyodaku, Tokyo, Japan
    Eur Neuropsychopharmacol 21:175-9. 2011
    ..In this article, we share our perspectives in the consideration of adaptive design clinical trials based on our experiences discussing adaptive design in clinical trial consultation meetings in Japan...
  87. ncbi How to kick-start your CAPA process
    Ken Peterson
    PathWise Inc, USA
    Biomed Instrum Technol 39:55-9. 2005
  88. ncbi Adverse events involving intravenous patient-controlled analgesia
    Cheryl S Hankin
    BioMedEcon, LLC, Moss Beach, CA 94038, USA
    Am J Health Syst Pharm 64:1492-9. 2007
    ..v. patient-controlled analgesia (PCA) postoperative use during a two-year index period...
  89. ncbi A new era of prospective real-world safety evaluation primary report of XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System condition-of-approval post-market study)
    Mitchell W Krucoff
    Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina 27705, USA
    JACC Cardiovasc Interv 4:1298-309. 2011
    ....
  90. ncbi Pediatric cardiovascular safety: challenges in drug and device development and clinical application
    Katherine E Bates
    Children s Hospital of Philadelphia, Division of Cardiology, 3401 Civic Center Blvd, Philadelphia, PA 19104, USA
    Am Heart J 164:481-92. 2012
    ..The discussions in this article summarize areas of emerging consensus and other areas in which consensus remains elusive and provide suggestions for additional research to further our knowledge and understanding of this topic...
  91. doi A pivotal medical-device case
    Gregory D Curfman
    N Engl J Med 358:76-7. 2008
  92. ncbi Median approval times for class III medical devices have been well above statutory deadlines set for FDA and CMS
    Annette M Zinn
    Health Aff (Millwood) 31:2304-13. 2012
    ..Congress should consider the underlying causes for these delays in the development of future modernization legislation...
  93. ncbi Regulatory device approval for stroke: fair and balanced?
    Larry B Goldstein
    Stroke 38:1737-8. 2007
  94. ncbi Introduction to the Food and Drug Administration (FDA) regulatory process
    Joseph L Hackett
    Office of In Vitro Diagnostic Device Evaluation and Safety, Food and Drug Administration, Rockville, MD, USA
    J Proteome Res 4:1110-3. 2005
    ..This law also introduced the requirement for premarket review of new versions of old devices and of fundamentally new medical devices...
  95. ncbi [Medical innovations in the area of conflict between certification and allowance]
    B Moller
    Medizinischer Dienst des Spitzenverbandes Bund der Krankenkassen e V, Essen
    Dtsch Med Wochenschr 135:2088-92. 2010
    ..The present article discusses both positions in the context of national and international legislation for the certification of medical devices and presents possible solutions...
  96. ncbi Medical device reporting: issues with Class III medical devices
    Jeffrey Zigler
    Musculoskeletal Clinical Regulatory Advisers MCRA in Washington, DC, USA
    Food Drug Law J 62:573-80. 2007
  97. ncbi Off-label use of interventional cardiovascular devices
    G Rigatelli
    Minerva Cardioangiol 55:425-6. 2007
  98. ncbi Current concepts in joint replacement
    A Seth Greenwald
    Orthopedics 30:699-700, 704. 2007
  99. ncbi Responding to three articles regarding vagus nerve stimulation (VNS) for depression
    Peter Lurie
    Biol Psychiatry 60:1382; author reply 1382-3. 2006
  100. ncbi Nociceptive trigeminal inhibition--tension suppression system: a method of preventing migraine and tension headaches
    Wesley E Shankland
    TMJ and Facial Pain Center, Columbus, Ohio, USA
    Compend Contin Educ Dent 23:105-8, 110, 112-3; quiz 114. 2002
    ..If this is the case, then dentists may be able to treat headache patients more effectively than previously suspected through the use of a dental appliance...
  101. ncbi Safety and effectiveness considerations for clinical studies of visual prosthetic devices
    Ethan D Cohen
    Division of Physics, Office of Science and Engineering Labs, Center for Devices and Radiological Health, HFZ130, 12725 Twinbrook Pkwy, Rockville, MD 20852, USA
    J Neural Eng 4:S124-9. 2007
    ..Similar to cochlear implants, a visual prosthesis is expected to last in the body for many years, and good pre-clinical and clinical testing will help ensure its safety, durability and effectiveness...

Research Grants38

  1. DEVICE FOR PROMOTING SURVIVAL OF CONGESTED TISSUE FLAPS
    John A Russell; Fiscal Year: 2010
    ..with the Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) and toward device approval via a Premarket Approval (PMA) application, and (2) Complete a clinical trial in human patients in which ..
  2. Engineered scaffolds for complex craniomaxillofacial reconstructions
    Francesco Migneco; Fiscal Year: 2012
    ..Furthermore, testing in a large pre-clinical animal model will give TRS the data necessary to support a 510K submission for FDA device approval.
  3. Rapid Bacterial Detection in Platelet Concentrates
    Gundu Rao; Fiscal Year: 2005
    ..performed by inoculation of apheresis platelets with the 14 FDA specified bacterial species required for device approval. Commercialization: The rapid detection system has substantial commercialization potential in that it can be ..
  4. ROLES OF BMP4 AND ITS REGULATION IN TOOTH DEVELOPMENT
    Jian Feng; Fiscal Year: 2004
    ..Feng also plans to attend a series of advanced courses, which include human research training, FDA drug and device approval and drug development, identification of funding sources, writing and presentation skills, statistics and data ..
  5. Nanostenting Hydrogels for Sinus Surgery
    RICHARD ORLANDI; Fiscal Year: 2004
    ..The results of these Phase I studies will determine the feasibility and the optimal chemical properties of a nanostenting HA gel for human trials. ..
  6. Pharmacotherapy for Minor Depression
    Robert Howland; Fiscal Year: 2004
    ..The results of this study will have profound public health implications by improving our understanding of the efficacy of SJW and standard antidepressants for the treatment of MinorD. ..
  7. Natural History of POP-- A Prospective Cohort Study
    Ingrid Nygaard; Fiscal Year: 2005
    ..The national cost burden is large. This project will provide fundamental data to guide future decisions about intervention threshold, preventative measures, and risk factor modification. ..
  8. Decision Making in End-Stage Heart Failure
    Paul Hauptman; Fiscal Year: 2006
    ..unreadable] [unreadable] [unreadable]..
  9. Lipoprotein Utilization and Oxidation in CHF
    Ulrich P Jorde; Fiscal Year: 2010
    ..If our hypotheses can be proven, they may lead to developments of new therapies to improve exercise capacity and longevity in patients afflicted with CHF. ..
  10. Optimization of TMS for Depression - Coordinating Center
    Mark George; Fiscal Year: 2009
    ..This coordinating Center Grant (CCG) application is submitted under a CSMD mechanism, linked to 4 clinical site grants (CSG). ..
  11. CHOLESTEROL & PLAQUE RUPTURE--WOMEN AND PLAQUE EROSION
    Renu Virmani; Fiscal Year: 2001
    ..In addition, analysis of plaque morphology in the animal model proposed in Project 4 will be carried out in project 1. ..
  12. MOOD EFFECTS OF DEEP BRAIN STIMULATION IN PARKINSONS
    Mark George; Fiscal Year: 2002
    ..Thus, we plan to use interleaved fMRI and DBS to directly examine the effects of DBS on hypothesized brain circuits and to correlate this with immediate and longer-term (4 week) behavioral outcomes (mood and cognition). ..
  13. Effectiveness of Asthma Care: The Asthma Policy Model
    A Paltiel; Fiscal Year: 2004
    ..Cloutier), biostatistical analysis (Dr. Kuntz), and simulation modeling and economic evaluation (Dr. Paltiel) to explore cost-effective solutions to the asthma epidemic. ..
  14. Harvard University Health Services Research Training Gr*
    Milton Weinstein; Fiscal Year: 2008
    ..This proposal will allow the next generation of these investigators to continue to address evolving issues in health services research. ..
  15. Treatment Models for Primary and Chronic HIV Infection
    Rochelle Walensky; Fiscal Year: 2005
    ..Rochelle Walensky with a firm basis for career development as an independent, patient-oriented clinical researcher at the interface of these critical areas. ..
  16. ANALYSIS OF MULTIPLE INFORMANT DATA IN PSYCHIATRY
    SHARON LISE TERESA NORMAND; Fiscal Year: 2010
    ..These novel and innovative methods will improve the assessment of treatment effects and will contribute to improving the health of the population. ..
  17. PARAMEDIC FIELD INITIATION OF MAGNESIUM NEUROPROTECTIVE
    Jeffrey Saver; Fiscal Year: 2003
    ..abstract_text> ..
  18. Annular and Sub-Valvular Repair Techniques for Ischemic Mitral Regurgitation: In-
    Ajit P Yoganathan; Fiscal Year: 2010
    ..abstract_text> ..
  19. Telerobotic Minimally Invasive ASD Repair
    Jeremy Cannon; Fiscal Year: 2002
    ..The initial experiments will be done with an open chest model and subsequently a port access procedure will be developed. ..
  20. Fluid Mechanics of the Mitral Valve: In Vitro Studies
    Ajit Yoganathan; Fiscal Year: 2004
    ..The use of state of the art measurement systems unavailable for in vivo use will yield significant results. ..
  21. Improving Flow Dynamics in Fontan Surgeries
    Ajit Yoganathan; Fiscal Year: 2006
    ....
  22. Human Subjects Research Protection Improvement Plan
    Jeffrey Silverstein; Fiscal Year: 2003
    ..abstract_text> ..
  23. Endogenous Opioid in Millimeter Wave-Induced Pain Relief
    Marvin Ziskin; Fiscal Year: 2004
    ..Results from the planned project will provide an appropriate scientific base for the introduction of MWT into clinical practice in patients with neuropathic pain conditions. ..
  24. UW Multidisciplinary Clinical Research Training (RMI)
    Richard Deyo; Fiscal Year: 2004
    ....
  25. Optimizing strategies for universal HIV testing
    Rochelle P Walensky; Fiscal Year: 2010
    ..The scientific basis for early detection of HIV infection and aggressive linkage to care has been successfully laid. The challenge now is to identify effective, affordable, and cost-effective implementation mechanisms. ..
  26. Evolution of seizure precursors in refactory epilepsy
    Brian Litt; Fiscal Year: 2008
    ....
  27. Optimization of TMS for Depression
    Mark George; Fiscal Year: 2009
    ..This clinical site grant (CSG) proposal is one of four scientifically identical proposals resubmitted under a CSMD mechanism.] ..
  28. Plaque Progression, Apoptosis and Inflammation
    Renu Virmani; Fiscal Year: 2005
    ..abstract_text> ..
  29. Fetal Wound Repair- Cellular and Molecular Mechanisms
    Thomas Krummel; Fiscal Year: 2005
    ..We are uniquely qualified to complete this proposal due to our long history of fetal wound healing research and our successful use of the cellular and molecular techniques described herein. ..
  30. NIAMS Muiltidisciplinary Clinical Research Center in...
    Richard Deyo; Fiscal Year: 2006
    ..It will require computer modeling, based on precedents in MR-PET scanning. We will determine if surgeons will accept the synthesized images as a replacement for CT-myelography for purposes of surgical planning. ..
  31. MODELING TREATMENT USE & EFFECTIVENESS IN MENTAL ILLNESS
    Sharon Lise Normand; Fiscal Year: 2007
    ..The methodological advances from this research will enable researchers, policy makers, and methodologists to better characterize factors impacting technology innovation/exnovation and to expand the inferences for usual care. ..
  32. THE ROLE OF LYMPHOCYTES IN CEREBRAL ISCHEMIC INJURY
    Kyra Becker; Fiscal Year: 2004
    ....
  33. Biologic Mechanisms:Tooth Movement & Craniofacial Adapta
    James Mah; Fiscal Year: 2005
    ..The audience of approximately 300 will be comprised of basic scientists (40%), clinicians (35%), and students (25%). A proceedings book will be published 8-10 months after the conference and distributed world-wide. ..
  34. CNS antigen sensitization in stroke.
    Kyra Becker; Fiscal Year: 2009
    ..Data derived from this study will be used to plan future trials of immunomodulation in patients with stroke. ..
  35. Evaluating the Link between HIV Prevention and Treatment
    A David Paltiel; Fiscal Year: 2010
    ....
  36. Measuring the Efficacy of Endovascular Treatment of AAA
    Peter Faries; Fiscal Year: 2007
    ..abstract_text> ..
  37. Safer Antithrombotic Therapy for Elderly ACS Patients
    Eric Peterson; Fiscal Year: 2006
    ..Finally, we will use established relations with professional societies and the VHA to widely disseminate our study's major findings. ..
  38. ESCAPE Mechanistic Substudies
    Robert Califf; Fiscal Year: 2003
    ..Catecholamines are also being collected at baseline and 3 months. In addition, the ESCAPE investigators are all ready capturing detailed demographic, clinical, and physiological information as part of the protocol for the primary study. ..