FDA product code MDD: Device, Dermal Replacement
MDD is the FDA product code for device, dermal replacement. It is a Class III device, reviewed by the General and Plastic Surgery panel. Devices under MDD reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 3 recalls for MDD devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Dermal Replacement |
| Device class | Class III |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for MDD devices
3 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-03-11.
Frequently asked questions
What is FDA product code MDD?
MDD is the FDA product code for device, dermal replacement. It is a Class III device, reviewed by the General and Plastic Surgery panel.
What device class is MDD?
Class III. Typical premarket route: PMA.
Have MDD devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2016-03-11.
Next steps
- Run an FDA pathway report with predicate devices for product code MDD
- Run a recall and safety report across every MDD manufacturer
- Watch product code MDD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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