FDA 21 CFR 880: Docket FDA-2008-N-0106, 4/11

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Docket FDA-2008-N-0106 was published on February 14, 2011, and went into effect on April 18, 2011.

Docket FDA-2008-N-0106 added section 880.6310, Medical Device Data Systems,ﾠto 21 CFR 880, General Hospital and Personal Use Devices.ﾠSection 880.6310 reclassified Medical Device Data Systems (MDDSs) from class III (pre-market approval) to class I (general controls).ﾠ

With this change, the FDA exempted MDDSs from pre-market notification requirements.