FDA product code PVH: Test, Opiates, Employment And Insurance Testing, Exempt
PVH is the FDA product code for test, opiates, employment and insurance testing, exempt. It is a Class II device, regulated under 21 CFR 862.3650 and reviewed by the Clinical Toxicology panel. Devices under PVH reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
The opiates test is an in vitro diagnostic test for the qualitative analysis of opiates for employment and insurance testing. FDA has exempted these devices from the premarket notification requirement by publishing in the Federal Register of July 11, 2017 (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices subject to the limitations under 21 CFR XXX.9, where XXX refers to Parts 862-892, and any limitations on the exemption described in (82 FR 31976). Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register (82 FR 31976) available at https://www.federalregister.gov/documents/2017/07/11/2017-14453/medical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce. If a manufacturers device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing.
Classification
| Field | Value |
|---|---|
| Device name | Test, Opiates, Employment And Insurance Testing, Exempt |
| Device class | Class II |
| Regulation | 21 CFR 862.3650 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) exempt |
Recalls for PVH devices
openFDA lists no recalls for product code PVH.
Frequently asked questions
What is FDA product code PVH?
PVH is the FDA product code for test, opiates, employment and insurance testing, exempt. It is a Class II device, regulated under 21 CFR 862.3650 and reviewed by the Clinical Toxicology panel.
What device class is PVH?
Class II, regulation 21 CFR 862.3650. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PVH
- Run a recall and safety report across every PVH manufacturer
- Watch product code PVH 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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