Navigation Links
FDA Finalizes Regulation For Certain Software, Hardware Used With Medical Devices
Date:2/14/2011

SILVER SPRING, Md., Feb. 14, 2011 /PRNewswire-USNewswire/ -- Today, the FDA announced a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.

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

"This rule is a common-sense regulatory approach that provides clarity and predictability for manufacturers of these data systems," said Jeffrey Shuren, M.D., director of the Center for Devices and Radiological Health. "This shows our flexibility in applying regulations for medical device data systems that are not overly burdensome for manufacturers but continue to assure that data stored, transferred or displayed on these systems remain reliable."

Medical Device Data Systems are off-the-shelf or custom hardware or software products used alone or in combination that display unaltered medical device data, or transfer, store or convert medical device data for future use, in accordance with a preset specification.

Examples of MDDS products include: devices that collect and store data from a glucose meter for future use or that transfer lab results to be displayed at a nursing station for future use.

Prior to this rule, first proposed in 2008, FDA considered these devices to be either Class III (or high-risk) devices requiring premarket approval or accessories to an existing medical device.

By down-classifying these devices into Class I, the FDA is exempting all manufacturers of MDDS from premarket notification and applying the level of regulation reserved for low risk devices. Moreover, these manufacturers must comply with all Class I requirements including registering with the FDA, listing their MDDS products, reporting adverse events and complying with FDA's Quality Systems regulation, a basic system of manufacturing and design controls that, among other things, will ensure manufacturers test their products before marketing them.

The rule also levels the playing field for medical device manufacturers. Information technology companies that design, install or market these systems, and hospitals that develop them in their facilities, must follow Class I requirements as well.

The Medical Device Data Systems rule will be published in the Federal Register tomorrow and is available for advanced viewing today.

For more information

Medical Device Data Systems

http://www.ofr.gov/OFRUpload/OFRData/2011-03321_PI.pdf

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.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. CeNeRx BioPharma Finalizes Plans to Initiate Phase II Trials for Its Novel Antidepressant Agent Tyrima(TM) Using Innovative Brain Imaging Study
2. Zimmer Finalizes Acquisition of Chinese Orthopaedic Implant Leader Beijing Montagne Medical Device Co., Ltd.
3. Scott & White Finalizes College Station Land Deal
4. Bionovos Drug Candidate for Menopausal Symptoms Shows Effect on Neural Pathways Related to Temperature Regulation
5. Addrenex Pharmaceuticals New Hires Further Company Goal to Identify New Drugs for Adrenergic Regulation
6. New Safety Regulations Drive Greater Need for Resources and Expertise at Every Stage of Clinical Development
7. GlaxoSmithKline and U.S. Patent and Trademark Office File a Motion to Dismiss Litigation Over Final Regulations
8. Somanetics Acquires Exclusive Sublicense to Cerebral Autoregulation Monitoring Technology Developed at The Johns Hopkins University
9. BNA Books Announces Publication of New 2009 Cumulative Supplement to Pharmaceutical Law: Regulation of Research, Development, and Marketing
10. VHGI Discusses Recent Addition to the Regulation SHO Threshold Security Listing
11. Renhuang to Launch New All-Natural Anti-depressant and Nerve Regulation Product - Compound Schisandra Tablets
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/10/2017)... July 10, 2017  BDI Group subsidiary Pathway ... support services organization serving specialty pharmacies, home infusion ... of four significant, value-added member programs designed to ... manage reimbursement and improve access and affordability for ... Pathway ...
(Date:7/5/2017)... Wolfmet 3D  printed tungsten collimator manufactured by M&I Materials ... combine to progress molecular radiotherapy imaging. In molecular ... to accurately quantify the radiation absorbed by those patients undergoing ... of this radiotherapy treatment has been available — that is, ... ...
(Date:7/1/2017)... Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today announced ... broadcast live over the Internet on Thursday, July 27, 2017, ... quarterly results will be made available at 7:30 a.m. Eastern ... live audio webcast can be accessed via Zimmer Biomet,s Investor ... for replay following the conference call. ...
Breaking Medicine Technology:
(Date:7/18/2017)... ... 18, 2017 , ... CannaKids, a California Cooperative Cooperation that specializes in the ... the WORLDZ Summit, taking place in Hollywood from July 31-August 1, the Company’s ... cannabis for both pediatric and adult patients, and how the path has led her ...
(Date:7/18/2017)... ... 2017 , ... Doctors on Liens, the leading network of ... who offer the most effective and efficient care on a lien basis. Doctors ... each patient receives prompt and courteous service, same or next day appointments, and ...
(Date:7/18/2017)... ... July 19, 2017 , ... USHEALTH Group, ... Responsibility Initiative in the prestigious CEO World Awards®. The coveted annual CEO ... products and services, CEO case studies, corporate social responsibility, and milestones from every ...
(Date:7/17/2017)... ... ... McGraw Family Pledges $3 Million for New Learning Center at Norwalk Hospital, New ... NORWALK, Connecticut – July 17, 2017 – The McGraw family, founders of global multimedia ... up to $3 million in a challenge gift to establish the new McGraw Family ...
(Date:7/17/2017)... ... July 17, 2017 , ... Western University of Health Sciences ... Higher Education for the sixth consecutive year, and also made the Honor Roll ... and Lebanon, Oregon, was recognized in seven categories: Collaborative Governance, Compensation & Benefits, ...
Breaking Medicine News(10 mins):