FDA 21 CFR 880: General Hospital and Personal Use Devices
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21 CFR 880, General Hospital and Personal Use Devices, defines the FDA’s classification of commercially distributed hospital and personal use devices intended for human usage.ﾠ
As of April 18, 2011, Docket FDA-2008-N-0106 went into effect.ﾠThis added section 880.6310, Medical Device Data Systems, to 21 CFR 880.
Section 880.6310 re-classifies 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.
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FDA 21 CFR 880: Docket FDA-2008-N-0106, 4/11
This FDA docket went into effect on April 18, 2011. With this change, the FDA exempted MDDSs from pre-market notification requirements.
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FDA Guidance: Medical Device Data Systems, Image Storage Devices, and Image Communications Devices, 2/15
In February, 2015, the FDA published this guidance to inform that they does not intend to enforce compliance with the regulatory controls for Medical Device Data Systems.
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FDA Presentation: Mobile Medical Apps, MDDS, General Wellness Apps, 2/15
FDA presentation to clarify guidance documents for Mobile Medical Applications, General Wellness Applications, and Medical Device Data Systems.
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