Guidance: How To Profit From Humanitarian-Use Devices In Pediatric Patients
This article was originally published in The Gray Sheet
Executive Summary
1Draft guidance issued Aug. 5 clarifies FDA's new policy for allowing companies to profit from humanitarian-use devices in pediatric populations
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Regulatory News In Brief
Neuro/physical medicine device reg: Neurological and physical medicine manufacturers want extra time to comment on a proposed rule and draft guidance documents that would establish special controls for 11 device types and exempt six of the device types from 510(k) pre-market submission requirements, provided they follow the special controls (1"The Gray Sheet" April 5, 2010). Comments on FDA's April 5 proposals were due July 6, but DJO, Slendertone, Electrostim Medical Solutions Inc., and the Neurostimulation Device Alliance say they'll need "adequate time for careful consideration of the technical issues and the clinical implications of the proposed special controls." In June 2 comments, Titan Medical "vehemently" opposes easing regulation of transcutaneous electrical nerve stimulator (TENS) devices, arguing that the proposed new process could pose safety issues. Titan also raises the question of whether "less effective" devices allowed on the market will be reimbursed by payers under the same codes as 510(k) products. "How do payers differentiate between the two types?" the firm asks