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

new medical device technologies.  

The Federal Register notice also outlines the agencies' commitment to ensuring that submitted data is confidential and highlights when sponsors can opt-out of the parallel review program.  

The pilot program, which will last for up to two years with the possibility for extension, will focus on innovative technologies that can benefit from the efficiencies of parallel review. The pilot program will accept no more than three to five submissions per year.

In September 2010, the FDA and CMS announced their intention to implement a parallel review process, and received 37 public comments, which can be found in the public docket.

For more information and to read the Federal Register notice:

FDA-CMS Premarket Review

http://www.fda.gov/parallel-review.

Medicare Coverage Center

http://www.cms.gov/center/coverage.asp

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

For Immediate Release: Oct. 7, 2011
Media Inquiries: FDA – Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov;
CMS – Media Relations Group, 202-690-6145, OEABox@cms.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
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:10/20/2014)... -- Indianapolis interventional medical device maker NICO Corporation ... visualization leader Synaptive Medical announced today ... that they have joined forces to integrate their ... the first of its kind and will make ... BrainPath® interventional access technology and Synaptive,s BrightMatter™ real-time ...
(Date:10/20/2014)...  ResMed (NYSE: RMD ) today ... program, a comprehensive suite of software and service ... health care providers. ResMed Data ... information. It integrates valuable sleep and respiratory treatment ... platforms with customers, in-house or third-party electronic health ...
(Date:10/20/2014)... BioNano Genomics announced today achievement of a major milestone ... at 30X depth, sufficient for a genome map, in 24 ... and demonstrated for the IrysChip TM V2, the high-throughput ... will be rolled out to BioNano,s collaborators and customers over ... at the American Society for Human Genetics (ASHG) 2014 ...
Breaking Medicine Technology:Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 2Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 3Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 4Indianapolis' NICO Corporation and Toronto's Synaptive Medical, Inc. Announce First-Ever Intervention-Visualization Partnership with Goal to Improve Standard of Care in Neurosurgery 5ResMed Launches ResMed Data Exchange 2BioNano Genomics Announces One Human : One Chip : One Day 2BioNano Genomics Announces One Human : One Chip : One Day 3
... (NYSE: AZN ) announced today that the ... complete response letter (CRL) for the New Drug Application ... In the CRL, the FDA requested additional ... request that additional studies, including clinical studies, be conducted ...
... 2010 Insmed Incorporated (Nasdaq CM: INSM), a biopharmaceutical company, ... 16, 2010, from The NASDAQ Stock Market, notifying Insmed that ... until June 13, 2011, to regain compliance with the $1.00 ... The NASDAQ Capital Market, as set forth in NASDAQ Listing ...
Cached Medicine Technology:AstraZeneca Receives Complete Response Letter From US FDA For BRILINTA™ (Ticagrelor Tablets) 2NASDAQ Grants Insmed Incorporated 180-Day Extension to Regain Compliance with Minimum Bid Price Rule 2
(Date:10/22/2014)... Lexington, Kentucky (PRWEB) October 22, 2014 ... an agreement that will change the current location of ... Road to South Limestone across from the University of ... be a state-of-the-art ambulatory care center, owned and operated ... meet the orthopaedic needs of children and their families ...
(Date:10/22/2014)... Los Angeles, California (PRWEB) October 22, 2014 ... Recovery 2.0: Move Beyond Addiction and Upgrade Your Life (Paperback; ... the field of Yoga & Recovery. This book is ... and thrive in a life of recovery. , Recovery ... of the 12 Steps; Recovery 2.0 is a guide for ...
(Date:10/22/2014)... 2014 During the Western United States’ ... runs dangerously low, Southern Oregon’s water is proving resistant ... the lowest mountain snow pack on record in 2014, ... early autumn.* That was the observation of journalist-hikers Art ... “Hiking Southern Oregon,” during an interview with water advocate ...
(Date:10/22/2014)... 2014 Healthcare professionals who are ... education at home or on-the-go via laptops, tablets ... brand new, premium Seminar-on-Demand CE courses. The new ... 2,000 hours of CE course offerings, ... experience. With such a diverse library, there’s something ...
(Date:10/22/2014)... 22, 2014 Although there are only 24 hours ... many people who have trouble finding time within their busy schedules ... for long periods of time to get in shape. Here are ... on the go. , Change Up Your Commute , Consider ... to add some exercise into your daily routine. If you must ...
Breaking Medicine News(10 mins):Health News:Shriners Hospitals for Children - Lexington Announces Plan to Build New $47 Million Facility 2Health News:Shriners Hospitals for Children - Lexington Announces Plan to Build New $47 Million Facility 3Health News:Hay House Announces The Official Release of Recovery 2.0: Move Beyond Addiction and Upgrade Your Life 2Health News:Hay House Announces The Official Release of Recovery 2.0: Move Beyond Addiction and Upgrade Your Life 3Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 2Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 3Health News:Southern Oregon Is West’s Most Drought Proof Fresh Water Region Say Hiking Guide Authors 4Health News:Top Provider of Continuing Education at Home Releases 20 New Online Courses 2Health News:HealthGuideMD Presents Ways to Improve Your Exercise and Fitness 2
... behind her dramatic weight loss over the past few months, and ... ,Jolie told reporters at the New York premiere ... lost weight is because shes not only still grieving over the ... in January, but also busy running around four young kids. ...
... some extra sleep before a big game could improve ... Cheri Mah and colleagues at Stanford University observed six ... were told to maintain their usual sleeping habits for ... were instructed to get as much extra sleep as ...
... study has found that obesity, high blood pressure, high cholesterol, ... age group of 18 24. , The ... Lofgren, Joanne Burke, Ruth Reilly and Jesse Morrell, at the ... study, researchers collected data from more than 800 undergraduates enrolled ...
... Salk Institute for Biological Studies have found in a study ... in everyday life, may contribute to the accumulation of ... Alzheimers disease. ,The researchers say that while aging ... number of studies have pointed to stress as a contributing ...
... are affected by scorching temperatures . ,Dogs in Jaipur ... canines being treated at veterinary hospitals everyday. ,Veterinarians ... don't have any sweat glands to keep cool. The sick ... treatments to bring their body temperature to normal. ...
... could save her so much time and money. But after a ... Africa's largest slum, she realized it could. ,With ... that uses human waste to produce gas to burn to heat ... ,"At first I thought it was a very strange idea - ...
Cached Medicine News:Health News:Emotional Stress Could Be a Factor in Causing Alzheimers: Study 2Health News:Bio-latrine Cleans Up Kenyan Slum and the Environment 2Health News:Bio-latrine Cleans Up Kenyan Slum and the Environment 3
ACE Control Serum provides the laboratory with vital information on the performance of the ACE chemistry assay....
Medical Claims Billing...
e-MDs Bill practice management system is used in the medical billing cycle....
BillingPro...
Medicine Products: