Modular PMA payment
This article was originally published in The Gray Sheet
Executive Summary
CDRH and the FDA chief counsel's office are formulating a user fee payment policy for modular PMAs that are currently in-house. The agency confirms that sponsors will have to pay user fees for review of pending modular PMAs, as suggested at a recent MDUFMA meeting (1"The Gray Sheet" Dec. 9, 2002, p. 5). "Our preliminary guidance has been that if something is in-house already, but is not completed, [the sponsor] will have to pay the fee," CDRH Deputy Director Linda Kahan reported during a recent Food & Drug Law Institute MDUFMA audioconference. "The question we are trying to figure out is when that fee should be paid," she added. One possibility would be for manufacturers to pay the fee when they submit the clinical module. Modular PMAs submitted after the user fee system kicks in will require payment with the first module, Kahan explained...