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 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

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:6/23/2016)... June 23, 2016 Roche (SIX: RO, ROG; ... for its Elecsys BRAHMS PCT (procalcitonin) assay as a ... septic shock. With this clearance, Roche is the first ... integrated solution for sepsis risk assessment and management. ... infection and PCT levels in blood can aid clinicians ...
(Date:6/23/2016)... Capricor Therapeutics, Inc. ... company focused on the discovery, development and commercialization ... in its ongoing randomized HOPE-Duchenne clinical trial (Halt ... its 24-patient target. Capricor expects the trial to ... 2016, and to report top line data from ...
(Date:6/23/2016)... -- Bracket , a leading clinical trial technology and ... platform, Bracket eCOA (SM) 6.0, at the 52 nd ... 2016 in Philadelphia , Pennsylvania.  A demonstration ... of its kind to fully integrate with RTSM, will be ... is a flexible platform for electronic clinical outcomes assessments that ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... 2016 , ... Quality metrics are proliferating in cancer care, and are derived ... eye of the beholder, according to experts who offered insights and commentary in the ... Care. For the full issue, click here . , For the American Society ...
(Date:6/26/2016)... ... June 26, 2016 , ... PawPaws brand pet supplements ... was developed to enhance the health of felines. The formula is all-natural and is ... herbs in the PawPaws Cat Kidney Support Supplement Soft Chews are Astragalus ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American ... Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. ... including advance care planning, healthcare costs and patient and family engagement. , AIR ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture ... said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package ... Final Cut Pro X . Simply select a ProHand generator and drag it ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... recover from injury. Recently, he has implemented orthobiologic procedures as a method for ... is one of the first doctors to perform the treatment. Orthobiologics are substances ...
Breaking Medicine News(10 mins):