FDA product code QMC: Transport Medium, Notified Per The Vtm Guidance

QMC is the FDA product code for transport medium, notified per the vtm guidance. It is a Class I device, regulated under 21 CFR 866.2390 and reviewed by the Microbiology panel. Devices under QMC reach the market by 510(k); FDA lists no cleared 510(k)s for it. FDA has posted 4 recalls for QMC devices, 4 initiated in the last five years.

Definition

Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus per the guidance (Notified transport media and collection devices intended for specimen collection and transport for use in detection of respiratory viruses including coronavirus).

Classification

Recalls for QMC devices

4 product recalls in 2 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2023-10-02.

Frequently asked questions

What is FDA product code QMC?

QMC is the FDA product code for transport medium, notified per the vtm guidance. It is a Class I device, regulated under 21 CFR 866.2390 and reviewed by the Microbiology panel.

What device class is QMC?

Class I, regulation 21 CFR 866.2390. Typical premarket route: 510(k).

Have QMC devices been recalled?

Yes: 4 product recalls across 2 recall events; the most recent began 2023-10-02.

Next steps

• Run an FDA pathway report with predicate devices for product code QMC
• Run a recall and safety report across every QMC manufacturer
• Watch product code QMC 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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