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.

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