Navigation Links
FDA, CMS Launch Pilot Program for Voluntary Parallel Review of Innovative Devices
Date:10/7/2011

SILVER SPRING, Md., Oct. 7, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services (CMS) today launched a "parallel review" pilot program for concurrent review of medical devices for FDA approval and Medicare coverage.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

The FDA and CMS, which will begin accepting submissions today, issued procedures for voluntary participation and guiding principles that the agencies will follow during product review. The FDA and CMS anticipate that parallel review will facilitate the development of innovative new products and increase the efficiency of the review processes for both agencies.

"The pilot program will help the FDA and CMS streamline the parallel review process so that it works efficiently for expedient patient access to safe and effective medical devices," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health.

Often, device sponsors focus solely on obtaining FDA approval, only to find that Medicare coverage is not automatically forthcoming. Both agencies rely on clinical data in reaching their decisions, and while the two agencies have distinctly different regulatory responsibilities, parallel review can reduce time between FDA approval and Medicare national coverage determinations.

"The parallel review program has the potential to increase patient access to innovative devices that improve clinical outcomes. Our goal is to reduce regulatory burden and improve patient outcomes," said Patrick Conway, M.D., CMS chief medical officer.

The pilot program, announced in a Federal Register notice posted for advanced viewing today, is voluntary and will not change the existing separate and distinct review standards for FDA device approval and CMS coverage determination. It is only available for qualifying
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. CelsyaLife.com Set to Launch at "Walk to End Alzheimers"
2. New Report Details Launch Investment Levels for Pharmaceutical Industry
3. In Honor of National Breast Cancer Awareness Month, Alma Lasers Launches Nationwide Radiation Tattoo Removal Program, Declare Your Freedom
4. Incisive Surgical Launches New National Patient Advocacy Campaign -- Eliminate Traumatic Metal Skin Staples for Routine Skin Closure
5. EMDT Launches New Specialist Conference on Managing Regulatory Change for Medical Devices
6. voiceTech Launches ServiceLink-Rx, the First Comprehensive Patient Communication Platform for Retail Pharmacies
7. ICU Medical Launches Neutron™ Needlefree Catheter Patency Device With Constant Neutral Pressure Backed by a $100,000 Guarantee to Reduce Catheter Occlusions
8. Hikma Enters the Moroccan Market Through the Acquisition of 63.9% of Promopharm and Will Launch a Mandatory Tender Offer for the Remaining 36.1%
9. Ventus Medical Launches Provent® Sleep Apnea Therapy in Australia and New Zealand
10. Brain Resource Launches MyCalmBeat Personal Stress Reduction Monitor at Health 2.0
11. Reiki Awakening Academy Launches Online Innovative Face-to-Face Intuitive Development on the Internet
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/21/2014)... Aug. 21, 2014  The board of directors of ... provider of clinical trial imaging solutions, today announced that ... financial officer, effective immediately.  Mr. Groff has held the ... He joined VirtualScopics in January 2006 as an accounting ... "When the board of VirtualScopics asked Jim ...
(Date:8/21/2014)... (NASDAQ: CYBX ) today announced results for the ... 1   Operating results for the first quarter ... 2014, and other achievements, include: , Worldwide net product ... Strong international net sales of $13.2 million, an increase of ... product sales reached a new high of $58.8 million, an ...
(Date:8/20/2014)... Aug. 20, 2014 Northstar Global Business ... after months of hard work from many talented ... Snorenz formulation and package design.  The new formulation ... back into the product due to overwhelming evidence ... effects.  Snorenz Nighttime will also include these vitamins, ...
Breaking Medicine Technology:VirtualScopics, Inc. Names James Groff Chief Financial Officer 2VirtualScopics, Inc. Names James Groff Chief Financial Officer 3VirtualScopics, Inc. Names James Groff Chief Financial Officer 4Cyberonics Reports Fiscal 2015 First Quarter Results 2Cyberonics Reports Fiscal 2015 First Quarter Results 3Cyberonics Reports Fiscal 2015 First Quarter Results 4Cyberonics Reports Fiscal 2015 First Quarter Results 5Cyberonics Reports Fiscal 2015 First Quarter Results 6Cyberonics Reports Fiscal 2015 First Quarter Results 7Cyberonics Reports Fiscal 2015 First Quarter Results 8Cyberonics Reports Fiscal 2015 First Quarter Results 9Cyberonics Reports Fiscal 2015 First Quarter Results 10Cyberonics Reports Fiscal 2015 First Quarter Results 11Cyberonics Reports Fiscal 2015 First Quarter Results 12Cyberonics Reports Fiscal 2015 First Quarter Results 13Cyberonics Reports Fiscal 2015 First Quarter Results 14Cyberonics Reports Fiscal 2015 First Quarter Results 15Cyberonics Reports Fiscal 2015 First Quarter Results 16Northstar completes the first phase of its new retail strategy and prepares to ship reformulated Snorenz with all new packaging 2
... Mettler-Toledo International Inc. (NYSE: MTD ) today ... Life Sciences Conference in New York on Wednesday, September 21, ... webcast of the presentation, visit the investor relations page on ... of the webcast will be available for seven days. ...
... Sept. 14, 2011 Micross Components, a leading ... Deley as General Manager of its US Products ... in product and business development, will play a ... and its offerings to increase market share across ...
Cached Medicine Technology:Micross Components Names Mike Deley as General Manager of US Products & Services Division 2
(Date:8/21/2014)... Steven Reinberg HealthDay ... An experimental drug shows promise in treating respiratory syncytial virus ... "We are finally making major progress in being able ... cause of serious viral pneumonia, second only to influenza virus," ... at the University of Tennessee College of Medicine in Memphis. ...
(Date:8/21/2014)... and American Associations for Dental Research (IADR/AADR) have published ... Five Decades of Decline." This study, by lead researcher ... USA, follows edentulism (tooth loss) over the last hundred ... and requiring dentures. It is published in the OnlineFirst ... ( JDR ). , The researchers of ...
(Date:8/21/2014)... (PRWEB) August 21, 2014 According ... Resin (Acrylic, Polyester, Alkyd, Epoxy, Polyurethane, PTFE, PVDF, ... Industrial, Protective, Wood, Marine, Packaging, Coil, & Others) ... The global Waterborne Coatings Market is estimated to ... market Data Tables and 28 figures spread through ...
(Date:8/21/2014)... Competing in the “Best TV show” category, ... on Monday, August 25th at 7 pm at the ... festival is named in top festival lists and is ... Avid, and Write Brothers. , The event will occur ... at 410 South Myrtle Avenue (showtimes: 626-305-SHOW; email: monrovia(at)kptmovies(dot)com). ...
(Date:8/21/2014)... August 21, 2014 According to a ... Feeding Devices Market (Enteral Feeding Tubes, Enteral Feeding Pumps, ... Industry Analysis, Size, Share, Growth, Trends and Forecast,2013 - ... at USD 2.0 billion in 2012 and is estimated ... in 2019growing at a CAGR of 6.2% from 2013 ...
Breaking Medicine News(10 mins):Health News:New Drug May Fight Serious Respiratory Virus in Infants 2Health News:New Drug May Fight Serious Respiratory Virus in Infants 3Health News:Study shows steep decline in tooth loss, increase in socioeconomic disparities 2Health News:Waterborne Coatings Market worth $77,838.71 Million by 2019 – New Report by MarketsandMarkets 2Health News:Waterborne Coatings Market worth $77,838.71 Million by 2019 – New Report by MarketsandMarkets 3Health News:Waterborne Coatings Market worth $77,838.71 Million by 2019 – New Report by MarketsandMarkets 4Health News:“Heavy Metal Greg,” a Music Talk Show by Gregory Graham, Will Screen at Action on Film International Film Festival on 08/25/2014 2Health News:Enteral Feeding Devices Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2013 - 2019 2Health News:Enteral Feeding Devices Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2013 - 2019 3Health News:Enteral Feeding Devices Market: Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2013 - 2019 4
... ... The US Whey Proteins market is anticipated to reach 472.3 million pounds by 2015, driven ... technology of whey processing and investments in R&D are other major driving forces for the ... ...
... 1, 2010 - Shionogi Pharma, Inc., a U.S.-based group ... summarizing the results of two pivotal studies of the ... being developed for the treatment of primary premature ejaculation ... Urological Association (AUA) Annual Meeting in San Francisco. ...
... or too much/too little of the active ingredient , ... market them, men continue to buy them and experts ... for erectile dysfunction. , A new study, conducted in ... American Urological Association annual meeting in San Francisco, finds ...
... more females than males, organizers say , MONDAY, ... rates for women are generally on the downswing, ... rising, the American Lung Association (ALA) says. , ... from tobacco-related illness, the ALA estimates. And chronic ...
... ... Day. According to the World Health Organization, 1 billion people will die from ... given away to inform people about the significant adverse effect tobacco continues to ... No Tobacco Day on May 31. Download the e-book and access tools to ...
... caution , SUNDAY, May 30 (HealthDay News) -- New research ... bladder cancer and might even raise the risk of another ... researchers analyzed more than 10,000 questionnaires that men filled out ... than 60 percent of the men said they took supplements, ...
Cached Medicine News:Health News:US Whey Proteins Market to Reach 472.3 Million Pounds by 2015, According to New Report by Global Industry Analysts, Inc. 2Health News:US Whey Proteins Market to Reach 472.3 Million Pounds by 2015, According to New Report by Global Industry Analysts, Inc. 3Health News:Pivotal data for the investigational treatment PSD502 for primary premature ejaculation 2Health News:Pivotal data for the investigational treatment PSD502 for primary premature ejaculation 3Health News:Dangers Lurk in Impotence Drugs Sold on Web 2Health News:Women Smokers Targeted on 'World No Tobacco Day' 2Health News:Celebrate The World Health Organization's World No Tobacco Day, and Get Free eBook - Protect Women from Tobacco Marketing and Smoke 2Health News:Celebrate The World Health Organization's World No Tobacco Day, and Get Free eBook - Protect Women from Tobacco Marketing and Smoke 3Health News:Celebrate The World Health Organization's World No Tobacco Day, and Get Free eBook - Protect Women from Tobacco Marketing and Smoke 4Health News:Celebrate The World Health Organization's World No Tobacco Day, and Get Free eBook - Protect Women from Tobacco Marketing and Smoke 5Health News:Celebrate The World Health Organization's World No Tobacco Day, and Get Free eBook - Protect Women from Tobacco Marketing and Smoke 6Health News:Vitamins Fail to Protect Men Against Bladder Cancer 2
... The RSV OIA test features a ... your results. Approved for children under age ... provides an answer in just over 15 ... will enable you to decrease costs for ...
The GC OIA test is a rapid assay for the diagnosis of gonorrhea. Thermo solved the challenge of developing a specific rapid assay for Neisseria gonorrhea by using the proprietary ribosomal protein, ...
... A/B test combines performance equivalence to 14-day viral ... or B with a simple, easy-to-use test with ... has all the same procedural steps as our ... you decrease costs for unnecessary ancillary testing, improve ...
... Strep test delivers excellent sensitivity and specificity for ... simple, easy-to-use test that provides an answer in ... you to provide improved patient care with a ... laboratories. Find out what value we bring to ...
Medicine Products: