Navigation Links
Northwestern Survey Finds FDA Predictability a Top Concern Among Medtech Firms; Europe Preferred for Product Approval
Date:5/24/2011

estigator Jan B. Pietzsch, PhD, president and CEO of the technology consultancy Wing Tech Inc., and a consulting associate professor in Stanford University's Biodesign program and department of management science and engineering, emphasized that the survey offers both industry and FDA opportunities to improve the 510(k) pathway, and that collaboration is needed to secure the future of medical innovation in the United States and patient access to the safest and most-effective medical devices in the world. Among opportunities identified in the survey:

  • Respondents stated that their companies could have improved the initial submission for 39% of applications submitted in the past three years.
  • On average, respondents felt that 26% of FDA's follow-up questions should have been anticipated.

  • "The responses indicate that there may be opportunities for industry to better anticipate FDA's evidentiary needs during the regulatory process, as long as they are clearly stated and communicated," said Pietzsch. "Similarly, the process would benefit from FDA better training inexperienced reviewers on how to treat submissions consistently." He added that 92% of respondents perceived a correlation between inexperienced reviewers and more FDA questions.

    The survey findings are timely, as FDA's Center for Devices and Radiological Health (CDRH) is weighing regulatory revisions that support innovation; bring important, safe, and effective technologies to patients quickly; and keep jobs in the United States. (See sidebar on how the Northwestern survey responses align with the CDRH's action plan of January 2011.) The agency has also commissioned the Institute of Medicine (IOM) to produce an independent review panel report, which is expected to be released this summer.

    Interviews with more than 80 medtech experts from FDA and industry informed the survey's content. For the s
    '/>"/>

    SOURCE The Institute for Health Technology Studies (InHealth)
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5

    Related medicine technology :

    1. Northwestern Memorial Maintains Top Status in Nursing Hospital Renewed for Nurse Magnet®
    2. Lung Cancer Patients the Centerpiece for Northwestern Medicine Quality of Care Study
    3. New Implant Device Remotely Monitors Heart Failure Patients at Northwestern Memorials Bluhm Cardiovascular Institute
    4. CellCyte Genetics Signs Collaborative Agreement With Northwestern Universitys Feinberg School of Medicine to Perform Disease Model Outcome Study of CellCytes CCG-TH30 Product Candidate
    5. Evanston Northwestern Healthcare Researchers Explain Effects of Large-Scale, Universal MRSA Surveillance Program That Supports Expanded Intervention
    6. Northwestern Memorial Study Tests Cancer Drug on Scleroderma Patients
    7. Northwestern Offers Clinical Research and Regulatory Administration Graduate Certificate Program
    8. Northwestern Memorial Transplant Program Initiates New Study
    9. Perceptive Informatics® Global Survey Results Indicate Growing Demand for CTMS to Assist in More Efficient Site Monitoring and Management
    10. Reportlinker Adds Advanced Lung Cancer in Patient Smoker with Squamous Cell: Clinical Insights from a US Oncologists Survey
    11. Transgenomic, Inc. Expands SURVEYOR® Scan Product Line With BRAF and PIK3CA Mutation Detection Kits
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:9/19/2014)... Sept. 19, 2014 "Copay coupons," ... sales of brand drugs among patients with prescription drug ... to a new report  from the Department ... Inspector General (OIG). Federal anti-kickback laws prohibit suppliers ... are subsidized by the federal government. ...
    (Date:9/19/2014)... DUBLIN , September 19, 2014 /PRNewswire/ ... http://www.researchandmarkets.com/research/s6g5wm/global ) has announced the addition of ... report to their offering. ... devices have been broadly classified into wide ... are used for the treatment of different ...
    (Date:9/19/2014)... 19, 2014  4WEB Medical announces the formal launch ... ankle osteotomy implants on the market today at ... meeting in Chicago .  The Osteotomy ... osteotomy needs with 74 size options included in one ... of only 15 to 18 implant sizes, which limited ...
    Breaking Medicine Technology:PCMA: New OIG Report Cites Drug Manufacturer "Copay Coupon" Use in Medicare Part D 2Global Gynecological Devices Market 2014-2018: Key Vendors are Bayer, Boston Scientific, CooperSurgical, Ethicon, Hologic, Medtronic, Olympus and Stryker 2Global Gynecological Devices Market 2014-2018: Key Vendors are Bayer, Boston Scientific, CooperSurgical, Ethicon, Hologic, Medtronic, Olympus and Stryker 34WEB Medical Unveils 3D-Printed Osteotomy Truss System 2
    ... WOONSOCKET, R.I. , July 30 MultiCell Technologies, Inc. ... fresh new look and updated information about discovery technology platforms and ... common questions. , , ... "The new website is designed to inform our shareholders, scientists and ...
    ... July 29 As of late, the most prominently ... Lap-Band procedure, a minimally invasive operation in which an adjustable ... in order to restrict food capacity and promote weight loss. ... Lap Band surgery without the use of the band ...
    Cached Medicine Technology:MultiCell Technologies Launches New Web Site 2MultiCell Technologies Launches New Web Site 3Sleeve Gastrectomy Procedure With Dr. Michael Feiz Serves as a Highly Effective Alternative to Lap Band Surgery 2Sleeve Gastrectomy Procedure With Dr. Michael Feiz Serves as a Highly Effective Alternative to Lap Band Surgery 3
    (Date:9/21/2014)... of an infant prior to 37 weeks of pregnancy ... over the past two decades. According to the ... affects nearly 500,000 babies each year, or one of ... has improved survival rates for preterm infants, questions remain ... preterm infants. , Research led by Barry M. Lester, ...
    (Date:9/21/2014)... Instituting a partial smoking ban at a homeless shelter ... levels, an indicator of exposure to cigarette smoke, and ... to new research. The University of Texas Health Science ... week in the journal Addictive Behaviors . , ... fallen to 18 percent among adults, but among homeless ...
    (Date:9/21/2014)... AstraZeneca’s Pulmicort is an ICS ... is used prophylactically for the maintenance treatment of ... budesonide, is an anti-inflammatory corticosteroid with a high ... includes the Pulmicort Flexhaler (budesonide) for adults and ... Pulmicort Respules for children between one and eight ...
    (Date:9/21/2014)... focus on the physical activity benefits of active play, ... that for children, playing has no goal it ... fun, done alone or with friends, and it represents ... to combat boredom, sadness, fear, or loneliness." "By focusing ... aside several aspects of play that are beneficial to ...
    (Date:9/21/2014)... London, United-Kingdom (PRWEB) September 22, 2014 ... Fergus Sweeney and Dr. Lilliam Rosario as keynote speakers ... Transparency”. Following keynotes from Dr. Ben Goldacre in ... Professor Lord Winston in 2011 , PhUSE again ... professions who are passionate about advancement of clinical information. ...
    Breaking Medicine News(10 mins):Health News:Research evaluates neurodevelomental and medical outcomes in single family room NICU 2Health News:Research evaluates neurodevelomental and medical outcomes in single family room NICU 3Health News:UTHealth researchers study impact of smoking ban in homeless shelter 2Health News:Pulmicort Asthma Market (Epidemiology, Etiology, Symptoms, Diagnosis, Pathology) Forecasts to 2023 in New Report Available at LifeScienceIndustryResearch.com 2Health News:Pulmicort Asthma Market (Epidemiology, Etiology, Symptoms, Diagnosis, Pathology) Forecasts to 2023 in New Report Available at LifeScienceIndustryResearch.com 3Health News:Pulmicort Asthma Market (Epidemiology, Etiology, Symptoms, Diagnosis, Pathology) Forecasts to 2023 in New Report Available at LifeScienceIndustryResearch.com 4Health News:Narrow focus on physical activity could be ruining kids' playtime 2Health News:PhUSE announces Final List of Industry Influencers as Keynote Speakers 2Health News:PhUSE announces Final List of Industry Influencers as Keynote Speakers 3
    ... the health of your family tree? While the relatives ... holiday, taking a good look at,the family health history ... Surgeon General Steven K. Galson, M.D., M.P.H., has,declared Thanksgiving ... everyone to use the occasion to discuss and identify ...
    ... Fla., Nov. 20 The State of ... Services has selected,U.S. Care Management (formally Specialty ... management services to assist in improving,birth outcomes ... births and high-risk infants among Medicaid participants ...
    ... (BMI) is associated with higher plasma volume, which may ... obese men, according to a study in the November ... suggested that prostate cancer screening may be adversely affected ... cancer can be compromised by any factor that decreases ...
    ... sick children, study finds , , TUESDAY, Nov. 20 (HealthDay ... at a children,s hospital can cut rates of patient ... care unit, a new study suggests. , "This is ... so that adds to the potential that having rapid ...
    ... how to keep hands clean, MORRIS PLAINS, N.J., Nov. ... his/her nose or mouth. Considering that,some viruses and bacteria can ... and desks that children touch throughout the,day, it is easy ... According to the Centers for Disease Control and Prevention ...
    ... for fourth year to support St. Jude in ... Ohio, Nov. 20 Kay Jewelers is joining St. Jude,Children,s ... Giving,campaign. This is the fourth year for the national campaign ... in fundraising campaigns. Thanks and Giving was created by ...
    Cached Medicine News:Health News:Acting Surgeon General Encourages Americans to Know Their Health History During Fourth Annual Family History Day 2Health News:Acting Surgeon General Encourages Americans to Know Their Health History During Fourth Annual Family History Day 3Health News:State of Arkansas Department of Human Services, Division of Medical Services Selects U.S. Care Management for High-Risk Obstetrics Health Management Program 2Health News:State of Arkansas Department of Human Services, Division of Medical Services Selects U.S. Care Management for High-Risk Obstetrics Health Management Program 3Health News:State of Arkansas Department of Human Services, Division of Medical Services Selects U.S. Care Management for High-Risk Obstetrics Health Management Program 4Health News:Obesity associated with lower PSA levels in men with prostate cancer 2Health News:Rapid Response Teams Can Save Hospitalized Kids 2Health News:Rapid Response Teams Can Save Hospitalized Kids 3Health News:Proper Hand Hygiene Is Key to Avoiding Illness During Cold and Flu Season 2Health News:Kay Jewelers Joins St. Jude Children's Research Hospital(R) to Kick Off Fourth Annual Thanks and Giving(R) Campaign 2Health News:Kay Jewelers Joins St. Jude Children's Research Hospital(R) to Kick Off Fourth Annual Thanks and Giving(R) Campaign 3
    ELISA kit for detection of the cardiac marker Myoglobin. Kit features interchangeable reagents, E-Z Process performed at room temp, and results in less than 1 hour!...
    ... intended for the quantitative determination of prolactin ... in the diagnosis and treatment of disorders ... BioCheck Prolactin Quantitative Test is based on ... immunosorbent assay. The assay system utilized sheep ...
    ... assay is an immunometric ('sandwich') ... of Prolactin in human serum ... sample is bound by 2 ... epitopes. One antibody is attached ...
    ... ELISA Kit is enzyme immunoassay kit ... Prolactin (PRL) concentration in serum. Enzyme ... determination of many protein hormones in ... sensitive, reproducible, rapid and specific assay. ...
    Medicine Products: