Disposable Insulin Device Gets FDA Clearance

(National Institutes of Health)

Valeritas Inc., a medical technology company in Bridgewater, New Jersey, says that the US Food and Drug Administration (FDA) has granted 510(k) clearance to the company’s V-Go disposable insulin delivery device. The company designed V-Go for the subcutaneous delivery of insulin in preset basal (low continuous) rates and with on-demand bolus (high volume) dosing for adult patients requiring insulin.

V-Go devices will be available in a preset basal rate to deliver 20, 30 or 40 units of insulin in one 24-hour period and on-demand bolus dosing in 2 unit increments of up to 36 units in one 24-hour period. Valeritas plans to commercialize the V-Go in the United States in 2011.

Section 510(k) of the Food, Drug and Cosmetic Act requires medical device manufacturers to notify FDA of their intent to market a medical device at least 90 days in advance, particularly for devices introduced into commercial distribution for the first time or those reintroduced that will be significantly changed or modified to the extent that their safety or effectiveness could be affected. Such changes or modifications could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.

*     *     *