FDA warns neonatal device company NeoChild

August 20, 2008

The US Food and Drug Administration (FDA) has issued a warning letter to NeoChild for alleged misbranding of its neonatal devices and procedural errors.

The US Food and Drug Administration (FDA) has issued a warning letter to NeoChild for alleged misbranding of its neonatal devices and procedural errors.

The FDA stated that the firm marketed its SafeChild System's enteral feeding tubes and extension sets before filing a premarket approval or getting 510(k) clearance. In addition, the July 29 letter stated that the silicone and polyurethane enteral feeding tubes and the PVC extension sets were not approved for an investigational device exemption.

NeoChild is to submit a premarket approval so the FDA can evaluate the information and decide whether the products may be marketed legally.

In addition, the FDA also cited NeoChild for failure to develop or implement written medical device report procedures from the time it started distributing devices in March 2007 to the date of an April inspection.