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COVID-19: String Of FDA Guidance Docs Lay Bare Enforcement Policies For Infusion Pumps, ECMO Devices, Thermometers, And More

 
• By Shawn M. Schmitt

In three separate immediately-in-effect guidance documents, the US agency says makers of infusion pumps and accessories, extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices, and remote ophthalmic assessment and monitoring devices can make “limited modifications” to those products so they can be used during the ongoing novel coronavirus crisis, without the need for firms to seek out a new 510(k). A fourth guidance says clinical electronic thermometers that aren’t yet 510(k)-cleared by the FDA can be distributed for use.

Guidance word written on wood block. Guidance text on table, concept.

The US Food and Drug Administration has released a quartet of guidance documents that lay out enforcement policies for infusion pumps, ECMO and cardiopulmonary bypass devices, ophthalmic devices, and electronic thermometers.

The immediately-in-effect guidances were issued in response to the ongoing COVID-19 crisis in the US; they will be revoked when...

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