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U.S. Department of Health and Human Services

Medical Devices

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Requirements for Health Care Facilities and Manufacturers

Who is an MDDS Manufacturer?

An "MDDS manufacturer" may be a health care 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 FDA does not consider the following activities to be "manufacturing" an MDDS:

  • Purchasing and using 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).
  • Purchasing and using an MDDS marketed by an MDDS manufacturer for purposes of interfacing with medical devices and performing functionality described in the MDDS rule (transfer, store, display, or convert data).

How to Comply with the Final Rule

Implementation Timeline:

The MDDS final rule became effective on April 18, 2011. All manufacturers of MDDS (including health care 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 and List with the FDA (90 days from FR 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)

Details of these actions are listed below.

Instructions for MDDS Manufacturers and Health Care Facilities Involved in Manufacturing MDDS:

The final MDDS rule does not require MDDS manufacturers (including health care facilities involved in manufacturing MDDS) to submit any premarket applications to FDA.

All MDDS manufacturers, including health care facilities that manufacturer MDDS, are required to follow the requirements for Class I medical devices, including:

  • Registering the establishment and listing all MDDS products on an annual basis. As part of the annual listing, any updated information on the listed products (e.g., new versions of software) should be included. Registration and listing includes:
    • Determining if you are manufacturing MDDS (see above).
    • Identifying the product you have manufactured, including new updates or versions of software.
    • Identifying addresses of the establishments that manufacture the MDDS.
    • Assigning an official correspondent who is designated by the owner/ operator of an establishment responsible for the annual registration of the establishment and the device listing. The official correspondent also receives correspondence from the FDA involving the owner/operator and any of the firm's establishments.
    • Reading and following the advice and instructions on how to register and list at FDA's Device Registration and Listing webpage.
  • Special Notes for Registration and Listing of MDDS:

    Please use the following codes for FDA's Registration and Listing System:

    • Product Code: OUG
    • Premarket Submission Number: [leave this blank]
    • Proprietary Name: [provide a generic system name (e.g., "X" Hospital MDDS)]
  • Reporting adverse events associated with the use of your device through FDA's MedWatch adverse event reporting system.
  • Applying the Quality Systems regulation (link to QSR from section 1), including design controls to ensure proper design methodologies are used to manufacture these systems.

* Please note that the requirements for Registration and Listing begin on May 18, 2011. The requirements for reporting adverse events and following Quality Systems regulations begin on April 18, 2012.

The FDA will use its standard programs, including periodic inspections and monitoring of adverse event reports, to ensure that these devices are meeting the requirements of the Food, Drug, and Cosmetic Act.

The FDA will continue to work with the American Hospital Association, ECRI Institute, the Association for the Advancement of Medical Instrumentation, and hospitals, industry and other stakeholders to gather input and help implement the MDDS regulation in a targeted and practical way.