MEDICAL DEVICE DATA SYSTEM RULE (MDDS Rule) - 21 CFR 880.6310

On February 15, 2011 the FDA published the medical device data systems final rule also referred to as the "MDDS Rule" - 21 CFR 880.6310.  The purpose of this rule is to reclassify medical device data systems from being a Class III that requires premarket approval to a Class I that requires General Controls of the Federal Food Drug & Cosmetic (FD&C) Act and is exempt from premarket notification requirements.   This rule is beneficial to medical device manufacturers of MDDS devices that previously were required to prepare and submit premarket notification and wait for premarket approval prior to marketing the device.  However, if a hospital or other health care facility modifies an existing MDDS software or hardware or develops its own hardware system that has intended use consistent with an MDDS the hospital or healthcare facility would become a medical device manufacturer and be subject to FDA's regulatory requirements.

According to the FDA, a MDDS device is defined as:

§ 880.6310 Medical device data system. -- (a) Identification.

1. A medical device data system (MDDS) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices:
   1. The electronic transfer of medical device data;
   2. The electronic storage of medical device data;
   3. The electronic conversion of medical device data from one format to another format in accordance with a preset specification; or
   4. The electronic display of medical device data.
2. An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.

Compliance Dates:

 May 18, 2011 - Deadline to register as a medical device manufacturer

April 18, 2012 - Deadline to implement a Quality System

Other References

FDA website - Medical Device Data System (MDDS)

FDA website - Quality System (QS) Regulation/Medical Device Good Manufacturing Practices

Hospitals Face FDA Inspections Under MDDS Rule

Focus Compliance & Validation Services can assist your organization with answering questions or how to comply with this new FDA regulation.  For more information or to contact us click here