Medical Device Data Systems

Medical Device Data Systems (MDDS) are hardware or software products that transfer, store, convert formats, and display medical device data.

An "MDDS manufacturer" may be a healthcare facility or manufacturer that is engaged in the following activities:

• Modifying a general purpose IT equipment/software or infrastructure for purposes of interfacing with medical devices and performing functionality described in the MDDS rule (transfer, store, display, or convert data).
• Labeling a general purpose IT equipment/software as a MDDS for purposes of interfacing to medical devices and performing functionality described in the MDDS rule (transfer, store, display, or convert data).
• Designing and implementing custom software or hardware for purposes of interfacing with medical devices and performing functionality described in the MDDS rule (transfer, store, display, or convert data).

The MDDS final rule became effective on April 18, 2011. All manufacturers of MDDS (including healthcare facilities that meet this definition) should be aware of the following key dates by which they are required to take specific actions:

• May 18, 2011: Manufacturers are required to register with the FDA (90 days from Federal Register notice on February 15, 2011)
• April 18, 2012: Manufacturers are required to implement a compliant Quality System and begin reporting adverse events (12 months from the date the rule became effective on April 18, 2011)

The following resources are provided.

AAMI

• FDA Aims to Exempt MDDS from Regulation June 2014
• Application of Quality Management System Concepts to FDA's MDDS Regulation April 2012
• The Medical Device Data System Rule: Are You in Compliance? June 2011
• Medical Device Software Committee

AAMI Standards and Guidance

• ANSI/AAMI/ISO 14971:2007/(R)2010, Medical devices - Application of risk management to medical devices
• ANSI/AAMI/ISO 13485:2003/(R)2009, Medical devices - Quality management systems - Requirements for regulatory purposes
• ANSI/AAMI/IEC 80001-1:2010, Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
• Getting Started with IEC 80001

FDA

• Webinar Slides: Overview of Medical Device Data Systems, General Wellness Devices, and Medical Device Accessories 02.25.15
• Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices: Guidance for Industry and Food and Drug Administration Staff 02.09.15
• FDA: Medical Device Data Systems
• Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Draft Guidance for Industry and Food and Drug Administration Staff June 20, 2014
• Federal Register, February 15, 2011: Medical Devices; Medical Device Data Systems Final Rule