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.
Publications199 found, 100 shown here
- Successful recruitment for medical device clinical studiesMaria 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...
- When to conduct a clinical trialJ 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...
- Who should protect the public? The Supreme Court and medical device regulationRussell Korobkin
UCLA School of Law, Los Angeles, USA
N Engl J Med 357:1680-1. 2007
- Ensuring safe and effective medical devicesDavid W Feigal
Center for Devices and Radiological Health, Food and Drug Administration, Rockville, MD, USA
N Engl J Med 348:191-2. 2003
- Making sense of the food and drug administrationJessica Anne Connor
Biodesign Surgical Innovation Program, Stanford University, Stanford, California 94305, USA
Semin Pediatr Surg 15:293-301. 2006....
- Medical device regulation: an introduction for the practicing physicianWilliam 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...
- FDA marketing claims, and the practitionerSusan 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....
- Evaluation of diagnostic imaging technologies and therapeutics devices: better information for better decisions: proceedings of a multidisciplinary workshopRobert M Califf
Duke Clinical Research Institute, Durham, NC 27715, USA
Am Heart J 152:50-8. 2006....
- Unanswered questions--drug-eluting stents and the risk of late thrombosisWilliam H Maisel
Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, USA
N Engl J Med 356:981-4. 2007
- Stent thrombosis redux--the FDA perspectiveAndrew 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
- Challenges in regulating breakthrough medical devicesNeal 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
- What the code of federal regulations means to youArthur 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
- Medical devices: the obvious, the readily-accepted, and the surprisingDeborah 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...
- Remarks of the Acting FDA Commissioner: FDLI's 48th annual conferenceLester M Crawford
Food and Drug Administration FDA, Rockville, MD, USA
Food Drug Law J 60:99-102. 2005
- US importer and distributor requirementsMaria Donawa
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...
- The FDA's role in medical device clinical studies of human subjectsJames 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...
- Devices and the food and drug administrationSteven J Phillips
Artif Organs 29:363-5. 2005
- FDA pilot programme in support of global harmonisationMaria 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...
- An overview of drug development in the United States and current challengesSharon 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...
- Medical device development: from prototype to regulatory approvalAaron V Kaplan
Section of Cardiology, Dartmouth Hitchcock Medical Center, One Medical Center Dr, Lebanon, NH 03756 0001, USA
Circulation 109:3068-72. 2004
- Regulatory issues for computerized electrocardiographic devicesNeal 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....
- Legal overprotectionJoseph H Friedman
Med Health R I 87:294. 2004
- Overview of success of EVAR: progress to dateG 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...
- Devices, drugs, and the Food and Drug Administration: increasing implications for ischemic strokeAnthony J Furlan
Department of Neurology, University of Massachusetts Medical School, Worcester, Mass 01605 2982, USA
Stroke 36:398-9. 2005
- Approval of the MERCI clot retriever: a critical viewKyra 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
- Economic implications of potential changes to regulatory and reimbursement policies for medical devicesShelby 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...
- Postmarket evaluation of breakthrough technologiesSunil V Rao
Duke Clinical Research Institute and Duke University Medical Center, Durham, NC 27705, USA
Am Heart J 156:201-8. 2008....
- In search of a coherent framework: options for FDA oversight of genetic testsGail H Javitt
Genetics and Public Policy Center, Berman Institute of Bioethics, Georgetown University Law Center, USA
Food Drug Law J 62:617-52. 2007
- Is that product safe? How to guarantee the integrity of medical supplies and tell staff about recallsLee 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...
- FDA medical device approval: things you didn't learn in medical school or residencyBarbara 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...
- Vioxx, radiology, and the Food and Drug AdministrationMichael J Pentecost
Department of Radiology, Georgetown University Medical Center, Washington, DC 20007 2197, USA
J Am Coll Radiol 2:394-7. 2005
- Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessmentMitchell 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...
- FDA-regulated validation in clinical and nonclinical environmentsConnie Curts
IEEE Eng Med Biol Mag 26:91-3, 101. 2007
- Insertion procedure, aftercare, and soft-tissue reaction of the 2.5-mm titanium tube system for a transcutaneous air conduction hearing aid systemTheo 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...
- Strategic planning for U.S. premarket approval submissionsMaria 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...
- Progress versus precision: challenges in clinical trial design for left ventricular assist devicesMichael 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...
- How are drugs approved? Part 1: the evolution of the Food and Drug AdministrationRobert 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...
- Medical devices post-approval studies program: vision, strategies, challenges and opportunitiesDanica 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
- 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
- Old customs, ancient lore: the development of custom device law through neglectRobert J Klepinski
Fredrickson and Byron, P A, Minneapolis, MN, USA
Food Drug Law J 61:237-49. 2006
- Ethics and the FDAJohn Fielder
IEEE Eng Med Biol Mag 25:13-7. 2006
- Change, but not in dollar bills. FDA needs more than money to fix problems: CongressJennifer Lubell
Mod Healthc 38:10-1. 2008
- Working together to enhance the efficiency of medical product developmentWendy R Sanhai
U S Food and Drug Administration, Rockville, MD, USA
J Nucl Med 49:43N-45N. 2008
- 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
- The U.S. FDA's involvement in the development and utilization of D11.40's standards on rubber consumer productsChiu 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
- Assessing the safety of the new 30-night contact lensesOliver 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
- Myths and realities in medical packagingR 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...
- What does it take? A case study of radical change toward patient safetyKim 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...
- Fighting fire with fire: new test standard benefits medical oxygen regulator designers and usersLori Kubinski
NASA White Sands Test Facility
Stand News 31:42-5. 2003
- Regulatory aspects of invasive glucose measurementsSteve 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...
- Managing changes during a clinical investigation, Part IMaria 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...
- Food and Drug Administration regulation of orthotic cranioplastyT 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...
- U.S. FDA rules for device investigationsRobert Munzner
IEEE Eng Med Biol Mag 22:95-6. 2003
- Ready, aim, fire! New IO device simplifies vascular access in severe casesJeff Lindsey
Estero Fla Fire Rescue, USA
JEMS 28:97-8. 2003
- Better health care with quality medical devices: FDA on the cutting edge of device technologySuzanne 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
- The Food and Drug Administration should regulate medical devices--not hospitalsNathan L Belkin
Am J Infect Control 31:499-501. 2003
- Scarred lives. A faulty jaw implant was recalled years ago; thousands of patients found out too lateDana Hawkins
US News World Rep 133:60-1. 2002
- The impact of FDA reformJanet 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...
- Wavefront-guided LASIK for the correction of primary myopia and astigmatism a report by the American Academy of OphthalmologySteven 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...
- Regulatory and medical-legal aspects of intraoperative monitoringMarc 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...
- Carotid stenting with distal protection in high surgical risk patients: the BEACH trial 30 day resultsChristopher 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)...
- The impact of technology on health care cost and policy developmentPaul 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...
- The CAPTURE registry: predictors of outcomes in carotid artery stenting with embolic protection for high surgical risk patients in the early post-approval settingWilliam 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.
- The CAPTURE registry: analysis of strokes resulting from carotid artery stenting in the post approval setting: timing, location, severity, and typeRonald 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...
- Rethinking analytical strategies for surveillance of medical devices: the case of hip arthroplastySharon Lise Normand
Department of Health Care Policy, Harvard Medical School, Boston, MA 02115 5821, USA
Med Care 48:S58-67. 2010Randomized trials that sometimes serve as the basis for device approval are small, short term, and generalizable to an increasingly smaller percentage of patients...
- Outcomes of care of abdominal aortic aneurysm in Veterans Health Administration facilities: results from the National Surgical Quality Improvement ProgramRuth 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 ..
- Urogynaecological research: current and future developmentsGunnar Lose
Department of Obstetrics and Gynecology, Glostrup Municipal Hospital, Ndr Ringvej, 2600, Glostrup, Denmark
Int Urogynecol J Pelvic Floor Dysfunct 18:599-601. 2007The 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 ..
- Clinical use of sirolimus-eluting stentsAjay 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...
- Development of a micromachined epiretinal vision prosthesisThomas 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.
- Review of the Medical Device DirectiveMaria 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...
- Quality assurance for antimicrobial devicesJ 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...
- Use of standards in the review of medical devicesCharles 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...
- Modeling for health care and other policy decisions: uses, roles, and validityM 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...
- [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...
- European Clinical Trials Directive: responses made to MHRA consultation letter MLX 287David J Flavell
Lancet 362:1415. 2003
- Setting the standardAdarsh Sandhu
Nat Nanotechnol 3:63-4. 2008
- Medical device innovation: prospective solutions for an ecosystem in crisis. Adding a professional society perspectiveMitchell 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...
- 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
- [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...
- Drug-eluting stents: caution and concerns for long-term outcomeRenu 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...
- Regulation of health-related technologies in GermanyM 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...
- Getting dumpedBrady Huggett
Nat Biotechnol 25:841-3. 2007
- Summary of the Food and Drug Administration's Circulatory System Devices Advisory Panel meeting December 7 and 8, 2006, Gaithersburg, MDKathryn C Coons
Division of Cardiology, Washington Hospital Center, Washington, DC 20010, USA
Cardiovasc Revasc Med 8:2-4. 2007
- Critical appraisal of medical devices in the management of cerebrovascular diseaseMichael 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 ..
- Effective standards and regulatory tools for respiratory gas monitors and pulse oximeters: the role of the engineer and clinicianSandy 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...
- Adaptive clinical trials for new drug applications in JapanYuki 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...
- How to kick-start your CAPA processKen Peterson
PathWise Inc, USA
Biomed Instrum Technol 39:55-9. 2005
- Adverse events involving intravenous patient-controlled analgesiaCheryl 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...
- 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....
- Pediatric cardiovascular safety: challenges in drug and device development and clinical applicationKatherine 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...
- A pivotal medical-device caseGregory D Curfman
N Engl J Med 358:76-7. 2008
- Median approval times for class III medical devices have been well above statutory deadlines set for FDA and CMSAnnette 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...
- Regulatory device approval for stroke: fair and balanced?Larry B Goldstein
Stroke 38:1737-8. 2007
- Introduction to the Food and Drug Administration (FDA) regulatory processJoseph 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...
- [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...
- Medical device reporting: issues with Class III medical devicesJeffrey Zigler
Musculoskeletal Clinical Regulatory Advisers MCRA in Washington, DC, USA
Food Drug Law J 62:573-80. 2007
- Off-label use of interventional cardiovascular devicesG Rigatelli
Minerva Cardioangiol 55:425-6. 2007
- Current concepts in joint replacementA Seth Greenwald
Orthopedics 30:699-700, 704. 2007
- Responding to three articles regarding vagus nerve stimulation (VNS) for depressionPeter Lurie
Biol Psychiatry 60:1382; author reply 1382-3. 2006
- Nociceptive trigeminal inhibition--tension suppression system: a method of preventing migraine and tension headachesWesley 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...
- Safety and effectiveness considerations for clinical studies of visual prosthetic devicesEthan 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...
- DEVICE FOR PROMOTING SURVIVAL OF CONGESTED TISSUE FLAPSJohn 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 ..
- Engineered scaffolds for complex craniomaxillofacial reconstructionsFrancesco 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.
- Rapid Bacterial Detection in Platelet ConcentratesGundu 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 ..
- ROLES OF BMP4 AND ITS REGULATION IN TOOTH DEVELOPMENTJian 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 ..
- Nanostenting Hydrogels for Sinus SurgeryRICHARD 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. ..
- Pharmacotherapy for Minor DepressionRobert 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. ..
- Natural History of POP-- A Prospective Cohort StudyIngrid 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. ..
- Decision Making in End-Stage Heart FailurePaul Hauptman; Fiscal Year: 2006..unreadable] [unreadable] [unreadable]..
- Lipoprotein Utilization and Oxidation in CHFUlrich 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. ..
- Optimization of TMS for Depression - Coordinating CenterMark George; Fiscal Year: 2009..This coordinating Center Grant (CCG) application is submitted under a CSMD mechanism, linked to 4 clinical site grants (CSG). ..
- CHOLESTEROL & PLAQUE RUPTURE--WOMEN AND PLAQUE EROSIONRenu 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. ..
- MOOD EFFECTS OF DEEP BRAIN STIMULATION IN PARKINSONSMark 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). ..
- Effectiveness of Asthma Care: The Asthma Policy ModelA 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. ..
- 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. ..
- Treatment Models for Primary and Chronic HIV InfectionRochelle 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. ..
- ANALYSIS OF MULTIPLE INFORMANT DATA IN PSYCHIATRYSHARON 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. ..
- PARAMEDIC FIELD INITIATION OF MAGNESIUM NEUROPROTECTIVEJeffrey Saver; Fiscal Year: 2003..abstract_text> ..
- Annular and Sub-Valvular Repair Techniques for Ischemic Mitral Regurgitation: In-Ajit P Yoganathan; Fiscal Year: 2010..abstract_text> ..
- Telerobotic Minimally Invasive ASD RepairJeremy Cannon; Fiscal Year: 2002..The initial experiments will be done with an open chest model and subsequently a port access procedure will be developed. ..
- Fluid Mechanics of the Mitral Valve: In Vitro StudiesAjit Yoganathan; Fiscal Year: 2004..The use of state of the art measurement systems unavailable for in vivo use will yield significant results. ..
- Improving Flow Dynamics in Fontan SurgeriesAjit Yoganathan; Fiscal Year: 2006....
- Human Subjects Research Protection Improvement PlanJeffrey Silverstein; Fiscal Year: 2003..abstract_text> ..
- Endogenous Opioid in Millimeter Wave-Induced Pain ReliefMarvin 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. ..
- UW Multidisciplinary Clinical Research Training (RMI)Richard Deyo; Fiscal Year: 2004....
- Optimizing strategies for universal HIV testingRochelle 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. ..
- Evolution of seizure precursors in refactory epilepsyBrian Litt; Fiscal Year: 2008....
- Optimization of TMS for DepressionMark George; Fiscal Year: 2009..This clinical site grant (CSG) proposal is one of four scientifically identical proposals resubmitted under a CSMD mechanism.] ..
- Plaque Progression, Apoptosis and InflammationRenu Virmani; Fiscal Year: 2005..abstract_text> ..
- Fetal Wound Repair- Cellular and Molecular MechanismsThomas 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. ..
- 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. ..
- MODELING TREATMENT USE & EFFECTIVENESS IN MENTAL ILLNESSSharon 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. ..
- THE ROLE OF LYMPHOCYTES IN CEREBRAL ISCHEMIC INJURYKyra Becker; Fiscal Year: 2004....
- Biologic Mechanisms:Tooth Movement & Craniofacial AdaptaJames 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. ..
- 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. ..
- Evaluating the Link between HIV Prevention and TreatmentA David Paltiel; Fiscal Year: 2010....
- Measuring the Efficacy of Endovascular Treatment of AAAPeter Faries; Fiscal Year: 2007..abstract_text> ..
- Safer Antithrombotic Therapy for Elderly ACS PatientsEric Peterson; Fiscal Year: 2006..Finally, we will use established relations with professional societies and the VHA to widely disseminate our study's major findings. ..
- ESCAPE Mechanistic SubstudiesRobert 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. ..