Medical Device Data System (MDDS) FDA Rule Changes

As reported here and here, the FDA is proposing to reclassify a MDDS from a Class III to a Class I medical device. On the surface this might seem like a big deal. If you read the fine print though (my highlight):

FDA has already recognized that the class III requirements are not necessary for ensuring the safety and effectiveness of MDDS devices and has been exercising enforcement discretion with MDDS device manufacturers. These firms have not been required to submit PMAs or meet other requirements typically required of manufacturers of class III devices, but the agency believes that all or nearly all firms in this industry have in place good business practices, including quality systems.

They're just formalizing already established practices.

Related posts:

  1. Connecting Computers to FDA Regulated Medical Devices
  2. FDA Recognition of Medical Device Standards for Interoperability
  3. FDA Regulation of Mobile Medical Apps

This entry was posted on Friday, February 8th, 2008 at 1:08 pm and is filed under FDA. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

One Response to “Medical Device Data System (MDDS) FDA Rule Changes”

  1. FDA IssuesFrom New MDDS Rule :: Medical Connectivity says:
    March 1, 2008 at 2:13 pm

    […] tip: Bob on Medical Device Software and Dave Shaver at […]

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