Navigation Links
FDA Finalizes Regulation For Certain Software, Hardware Used With Medical Devices

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.


"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

Media Inquiries: Karen Riley, 301-796-4674,

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:
(Date:6/24/2016)... , June 24, 2016 ... of the "Structural Electronics 2015-2025: Applications, Technologies, ... In-Mold Electronics, Smart Skin, ... Photovoltaics Structural electronics involves electronic ... load-bearing, protective structures, replacing dumb structures such as ...
(Date:6/24/2016)... , June 24, 2016 Dehaier Medical ... the "Company"), which develops, markets and sells medical devices ... , signed a strategic cooperation agreement with Hongyuan ... "Hongyuan Supply Chain") on June 20, 2016, to develop ... the strategic cooperation agreement, Dehaier will leverage Hongyuan Supply ...
(Date:6/24/2016)... 24, 2016 Research and Markets has ... Companion Diagnostic Tests" report to their offering. ... Diagnostics The World Market for Companion Diagnostics ... diagnostics. Market analysis in the report includes the following: ... Vitro Diagnostic Kits) by Region (N. America, EU, ROW), 2015-2020 ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... ... payment industry today announced its strategic partnership with Connance, a healthcare industry ... The two companies’ proven, proprietary technology combine to provide health systems, hospitals ...
(Date:6/26/2016)... , ... June 26, 2016 , ... On June 10-11, ... of the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, ... the city’s history as home to some of the world’s leading providers of cereal ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many ... been diagnosed with endometriosis. These women need a treatment plan to not only ... approach that can help for preservation of fertility and ultimately achieving a pregnancy. ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX ... Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over ... Cut Pro X . Simply select a ProHand generator and drag it above media ...
(Date:6/25/2016)... ... June 25, 2016 , ... On Friday, June 10, ... Bronze Wellness at Work award to iHire in recognition of their exemplary accomplishments in ... the 7th annual Maryland Workplace Health & Wellness Symposium at the BWI Marriott in ...
Breaking Medicine News(10 mins):