There is a lot happening on the medical device front these days around MDDS (Medical Device Data Systems) and the FDA is paying close attention with new regulations, guidance and requests for comment.
With the April 2012 compliance deadline less than 8 months away, AZBio Member John C. Hoffman of QMR is paying close attention too and keeping our community in the loop via the AZBio Resource Network Group on LinkedIn. If you and your team are working in the MDDS space, you’ll want to get connected and join the discussion.
In addition, QMR is offering an MDDS white paper with more information. If you would like a copy, contact QMR by clicking here.
What is MDDS?
- A new classification regulation effective February 2011
- 21 CFR 880.6310 – Medical device data system
- Initial MDDS registration was required by May 16th, 2011
- MDDS will be actively enforced beginning April 18th, 2012 through on-site FDA inspections
- Medical device data is electronic data that originates from a medical device
- MDDS reclassifies data systems that electronically:
- Transfer, store, convert or display medical device data
- Includes software, electronic or electrical hardware (including wireless), modems, interfaces and communication protocols
- MDDS does not include devices intended to be used in connection with active patient monitoring
MDDS Facts
- Medical device data always originates from a medical device
- Labeling can partially define the regulated system – i.e., what uses are claimed
- An MDDS may be a single component (storage, display, communication component), or any combination of these components
- An MDDS can initiate and control communication
- Data transmitted through an MDDS can control a device, but the control command must have originated from another device
- An MDDS can facilitate communication, but may not alter the data in transit
Potential MDDS or MDDS+ Systems
- Bedside data displays
- Customization to commercially purchased systems
- Work flow “wrappers”
- Clinical decision support systems
- IV Pump, Infusion, Dosing and Rx systems
- Nutrition and Wellness systems
- Ventilator management systems
- Anesthesia systems
- Sterilization and asset workflow systems
- Enroute (to medical facility) support systems
- Flight for life, ambulance
- Fetal monitor displays
- Echo cardiogram displays
- Medical data merged from numerous systems
- Custom interfaces for medical devices and clinical information systems
- Smart phone, PDA, iPad apps (Mobile Medical Apps)
MDDS descriptions courtesy of QMR.
The FDA has a lot going on to keep you in the loop too. Here are links to FDA public workshops, meetings, and guidance.
Mobile Medical Apps Public Workshop 9/12 – 13
IOM 510(k) Report Public Meeting 9/16
Medical Device Postmarket Surveillance Draft Guidance
Benefit-Risk Determinations in Medical Device Medical Device Premarket Reviews Draft Guidance
Design Considerations for Medical Device Pivotal Clinical Studies Draft Guidance
CDRH Learn: Medical Devices in the Home
About AZBio – The Arizona BioIndustry Association
Business + BioScience for a Better Arizona
AZBio is comprised of member organizations in business, research, government, and other professions involved in biosciences.
The Mission of AZBio is to serve our Members, both as organizations and as individuals, by providing access to the key resources, connections, and information that support their ability to Connect, Collaborate, Innovate and Succeed thus supporting the growth of a thriving economic ecosystem for Arizona’s Bioscience Industry.
About the AZBio Resource Network
The AZBio Resource Network is a AZBio member community of subject matter experts that meet monthly to connect, engage and collaborate. To learn more, join them the second Friday of each month at SkySong in Scottsdale, Arizona from 10:30 – noon. For more information visit AZBIO.org and click the calendar tab.
About QMR
QMR, LLC provides Quality Management and Regulatory Consulting Services including for ISO 9000/13485, FDA Compliance Consulting, Product Submissions, FDA 483/Warning Letter Responses, Quality Assurance and Management, Quality Systems Certification, Training and Vendor Sourcing.