Wednesday, June 25, 2014

FDA Issues Draft Guidance Regarding MDDS

The FDA has released draft guidance last Friday, stating that the agency considers medical device data systems (MDDS) to be safe and effective, and does not intend to regulate them.

According to the guidance, the FDA will not mandate compliance to controls related to MDDS, including registration, premarket review and postmarket reporting, if they do not aim to control or alter the function of any connected medical devices, but rather are intended to:

  • Facilitate electronic transfer or exchange of medical device data;
  • Store and retrieve medical device information, such as blood pressure data;
  • Convert medical device data from one format to another; and
  • Display medical device information.

Comments for the draft guidance will be accepted through August 19th.

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