FDA update – February 25, 2011

New MDDS Rule

The Food and Drug Administration (FDA), on its own initiative, is issuing a final rule to reclassify Medical Device Data Systems (MDDSs) from class III (premarket approval) into class I (general controls).

MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions without controlling or altering the function or parameters of any connected medical devices.

An MDDS is not intended to be used in connection with active patient monitoring. FDA is exempting MDDSs from the premarket notification requirements.

Falling outside the MDDS classification has two potentially opposite consequences.

  1. The product is not regulated by FDA at all.
  2. The product is a class II or III medical device.

Among those changes that enlarge the MDDS classification to include products that might have otherwise been unregulated are:

  • Software designed to convert medical device data from one computer language to another (e.g., HL7 to XML, PDF, etc.).
  • Hospital-derived software designed to have an intended use consistent with an MDDS.
  • Some workflow or billing systems that transfer, store, covert, or display medical device data.
  • Hardware, such as modems, that are expressly promoted as part of the system

Among those changes that enlarge the MDDS classification to include software that might otherwise have been in class II or III include:

  • Software that performed irreversible data compression
  • Any software intended for lay users.

The rule does not apply to Following categories:

  • Electronic health record (EHR), personal health record (PHR), computerized physician order entry (CPOE), e-prescribing or word processing systems. Laboratory information systems and picture archiving and communication systems (PACS)

FDA also made numerous changes just to clarify the scope which are as follows:

  • FDA tried to simplify the language by replacing the cumbersome phrase “real-time, active, or online patient monitoring” with simply “not intended to be used in connection with active patient monitoring”.
  • Category does not include software that calls for manual data entry.
  • FDA dropped the use of the words “exchange”,” retrieval”, “from a medical device”. Because use of these words would suggest that software that plays a more active role in interacting with medical devices might be swept into the MDDS category

Manufacturer Responsibilities and Timelines:

  • This rule is effective After April 18, 2011.
  • All MDDS manufacturers have 90 days after the date of publication (May 16, 2011 by my counting) to electronically register and list with FDA as a medical device manufacturer.
  • Manufacturers have 12 months to implement a compliant quality system, including Medical Device Reporting.
  • FDA expects all MDDS manufacturers to establish and maintain adequate design controls as part of their quality system.
  • FDA intend to enforce design control requirements for design changes to a currently marketed device once there is a design change.

For more information on this new rule contact us at info@mdiconsultants.com and ref: MDDS rule.