On February 15, 2011, the FDA published a final rule that clarifies that Medical Device Data Systems (MDDSs) are regulated by the FDA and establishes the regulatory requirements for these medical devices. See 76 Fed. Reg. 8637 (Feb. 15, 2011). Healthcare facilities and users should be aware that they will be deemed to be manufacturers subject to FDA requirements if they:

  • develop their own software protocols or interfaces for medical devices that have an intended use consistent with a MDDS;
  • modify or reconfigure a commercially available MDDS outside the original manufacturer’s specifications either for the user’s clinical use or for commercial distribution; or
  • add to or modify any non-MDDS hardware or software to enable the transfer, storage, conversion according to preset specifications, or display of medical device data for use in clinical practice.

FDA defines an MDDS as a device intended to perform one or more of the following uses, without controlling or altering the functions 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 present specification; or (4) the electronic display of medical device data. The rule excludes from the MDDS definition any devices intended to be used in connection with active patient monitoring.

If a healthcare facility is a manufacturer of a MDDS, it is subject to FDA requirements for Medical Device Reporting (i.e., adverse event reporting to FDA), corrections and removals (i.e., recalls) reporting and recordkeeping, establishment registration, and device listing. It also must comply with good manufacturing practices and product design requirements codified in FDA’s Quality System Regulation.

The new rule becomes effective April 16, 2011. After that time, FDA will begin active regulation of MDDS manufacturers and use its existing enforcement authorities and policies to enforce requirements applicable to MDDS medical devices. Thus, it is prudent for healthcare facilities to become familiar with the definition of a MDDS under the new rule, develop procedures to identify whether the facility or user is modifying a MDDS as a manufacturer, and ensure compliance with FDA requirements.

A recent King & Spalding client alert on this new rule is available by clicking here.