FY 2015 Medical Device User Fee Small Business Qualification and Certification - Guidance for Industry, Food and Drug Administration Staff and Foreign Governments

The Medical Device User Fee Amendments (MDUFA) require the payment of a user fee for most types of medical device applications. A business that is qualified and certified as a ?small business? is eligible for a substantial reduction in most of these...
Source: Food and Drug Adminstration (FDA): CDRHNew - Category: Medical Equipment Source Type: news