FDA product code HDT: Device, Intrauterine, Contraceptive And Introducer
HDT is the FDA product code for device, intrauterine, contraceptive and introducer. It is a Class III device, regulated under 21 CFR 884.5360 and reviewed by the Obstetrics and Gynecology panel. Devices under HDT reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
Called for PMAs in FR 5/5/86 PMAs to be filed by 8/4/86
Classification
| Field | Value |
|---|---|
| Device name | Device, Intrauterine, Contraceptive And Introducer |
| Device class | Class III |
| Regulation | 21 CFR 884.5360 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | PMA |
| Implant | Yes |
Recalls for HDT devices
openFDA lists no recalls for product code HDT.
Frequently asked questions
What is FDA product code HDT?
HDT is the FDA product code for device, intrauterine, contraceptive and introducer. It is a Class III device, regulated under 21 CFR 884.5360 and reviewed by the Obstetrics and Gynecology panel.
What device class is HDT?
Class III, regulation 21 CFR 884.5360. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code HDT
- Run a recall and safety report across every HDT manufacturer
- Watch product code HDT 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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