Navigation Links
West Wireless Health Institute Applauds House Passage of Bill to Streamline FDA Medical Device Approval Process, Expedite Mobile Medical App Guidance
Date:6/20/2012

SAN DIEGO, June 20, 2012 /PRNewswire-USNewswire/ -- The West Wireless Health Institute (WWHI) today applauded the U.S. House of Representatives for passing legislation that ensures patients will have timely access to safe medical devices at reduced costs.

(Logo: http://photos.prnewswire.com/prnh/20120606/DC19778LOGO )

Currently, the FDA's de novo process forces manufacturers of low-risk medical devices to submit a 510(k) application, complete a standard review, and obtain a "Not Substantially Equivalent" finding before they can submit a request to have the device reclassified from Class III into Class I or II.  This results in rare use of the de novo process and unnecessarily delays the ability of industry to get innovative technology into the hands of patients at lower costs.  WWHI worked with California Representatives Brian Bilbray and Lois Capps to improve this process as part of the "Food and Drug Safety and Innovation Act" (H.R. 5651).

"We commend Representatives Bilbray and Capps for their leadership in ensuring that new, innovative, low- to moderate-risk devices will reach patients more quickly by streamlining the FDA approval process," said Dr. Joseph Smith, Chief Medical and Science Officer of the West Wireless Health Institute. "Common sense policies create clear regulatory pathways and expedite the entry of new technologies into the health care system to lower the cost of care.  Many wireless devices lack predicates so the de novo reform is particularly helpful for them, and more importantly, it benefits patients with timely access to new medical devices."

Last fall, the WWHI President testified before the House Energy and Commerce Committee on the importance of streamlining FDA's de novo approval process. Those recommendations were later incorporated into the legislation offered by Reps. Bilbray and Capps and passed as part of the FDA bill today.  The legislation also clears the way for the FDA to issue mobile medical app guidance, rather than place a moratorium on FDA guidance exempting most mobile apps, smartphones, and distributors from excessive testing requirements.

"Mobile apps have revolutionized countless industries by putting the power of complex technologies into consumers' hands, yet regulators haven't issued clear guidance on the medical use of apps," said Smith.  "Providing expedited guidance and a clear pathway for mobile medical apps will get low-cost solutions like these into the hands of patients without needless delay."

ABOUT THE WEST WIRELESS HEALTH INSTITUTE

The West Wireless Health Institute (www.westwirelesshealth.org) is the only medical research organization in the world focused on lowering health care costs through technology and innovation. The Institute was founded in 2009 by the Gary and Mary West Foundation, and is based in San Diego, California, the global center for health care innovation.


'/>"/>
SOURCE West Wireless Health Institute
Copyright©2012 PR Newswire.
All rights reserved

Related biology technology :

1. First successful human results achieved: Implantable wireless microchip drug delivery device
2. Successful human tests for first wirelessly controlled drug-delivery chip
3. Low-cost paper-based wireless sensor could help detect explosive devices
4. Cambridge Healthtech Associates™ Co-Sponsors BIO Debrief Networking Reception with Xconomy
5. Healthpoint Biotherapeutics To Create State-of-the-Art Cell Sciences Manufacturing Facility
6. Economic Alliance of Greater Baltimore Inks Business Partnership with BioHealth Innovation to Bring Health and Life Sciences Research to Market
7. BioPharm Systems Launches Services to Help Phase I Clinics Implement Oracle Health Sciences LabPas
8. Mayor Bloomberg: Health Crusader or Nanny State Despot?
9. Is Brazil the Next Big Thing in Healthcare?
10. Luminex Corporation to Present at Jefferies 2012 Global Healthcare Conference
11. Auxilium Pharmaceuticals, Inc. to Present at the Jefferies 2012 Global Healthcare Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/20/2017)... MA (PRWEB) , ... January ... ... leader in Less Exposure Surgery (LES®) Technologies, announced today the next evolution ... PedFuse Pedicle Screw System platform). In contrast to the competition, SpineFrontier is ...
(Date:1/19/2017)... Research and Markets ... has announced the addition of the ... 2025" report to their offering. Report ... provides a detailed analysis on current and future market trends to identify ... market values as the base numbers Key market trends ...
(Date:1/19/2017)... MAYNARD, Mass. , Jan. 19, 2017 ... company focused on enhancing productivity in aquaculture and a ... ), announces that it has completed the listing of ... finalized the equity subscription from Intrexon. "AquaBounty,s ... Company that will broaden our exposure to the U.S. ...
(Date:1/19/2017)... , Jan. 18, 2017 The global ... USD 92.9 billion by 2025, according to a ... industry has been adaptive of the function of ... as 2002. Among the services outsourced, clinical trial ... instance, Johnson & Johnson was the first pharmaceutical ...
Breaking Biology Technology:
(Date:1/18/2017)... Jan. 18, 2017 MedNet Solutions ... supports the entire spectrum of clinical research, is ... record-breaking year for the organization in terms of ... MedNet,s eClinical products and services. The company,s exceptional ... success of iMedNet ™ ...
(Date:1/12/2017)... 12, 2017  New research undertaken by Fit Small ... future.  1,000 participants were simply asked which office technology had ... may consider standard issue.  Insights on what will ... gathered from futurists and industry leaders including Penelope Trunk ... .  Some of these findings ...
(Date:1/11/2017)...  Michael Johnson, co-founder of Visikol Inc. a company originally funded ... named to the elite "Forbes 30 Under 30" list in the ... in 20 fields nationwide to be recognized as a leader in ... selected. ... currently a PhD candidate at Rutgers University. ...
Breaking Biology News(10 mins):