Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Small business guidance: FDA issues the FY 2006 small business certification FDL-1guidance for medical device user fee discounts Aug. 17, incorporating modifications from the Medical Device User Fee Stabilization Act, signed into law Aug. 1. In addition to updates on small business thresholds, the document addresses how tax-exempt organizations can qualify as small businesses, the "first premarket application" full fee waiver and consequences for filing a false certification. Worksheet and certification forms are included with the document...