FY 2005 OCER Annual Report - MDUFMA Goals
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), amends the Federal Food, Drug, and Cosmetic Act (the Act) to provide FDA important new responsibilities, resources, and challenges. MDUFMA has three particularly significant provisions:
- User fees and performance goals for premarket reviews of PMAs, PDPs, premarket reports (a new category of premarket application for reprocessed single-use devices), certain supplements, and 510(k)s. These fees, together with additional appropriations, are intended to allow FDA to make significant improvements to review evaluation processes, reducing the time required to make new medical technologies available to health care professionals and patients.
- Accredited persons (third parties), under carefully prescribed conditions, may conduct Establishment inspections.
- New regulatory requirements for reprocessed single-use devices, including a new category of premarket submission, the premarket report.
These and other important provisions of MDUFMA affect many aspects of various CDRH and OCER programs.
OCER implements the MDUFMA-authorized program to accredit third persons (Accredited Persons) to conduct inspections of eligible manufacturers of Class II and Class III medical devices. This will help FDA focus its limited resources on higher-risk operations and give medical device firms operating in global markets an opportunity to efficiently schedule multiple inspections. FDA issued guidance to implement the new authority and published criteria for Accredited Persons (AP) in the Federal Register. AP applications were received, reviewed, and rated by the FDA review board. As a result, 15 third parties were selected to participate in the program. Since that time, two additional APs have been accredited bringing the total number to 17.
This program is independent of third party inspections performed under the current US/EC Mutual Recognition Agreement.
An establishment is a small business within the meaning of MDUFMA if they reported gross receipts or sales of no more than $30 million on their Federal income tax return for the most recent tax year. Establishments that are determined to be a small business are eligible to receive a reduced or waived user fee. In FY 2005, OCER received, evaluated, and responded to 674 Small Business Determinations (SBDs). The reviews of SBDs were all completed during the first 7 days after receipt, well within the 60 day mandated timeframe.
CDRH staffs were provided with 37 science courses in response to MDUFMA provisions. These courses were selected based on the MDUFMA requirements and the needs of the CDRH offices.
On November 18, 2004, the 2 nd Annual MDUFMA Stakeholder Meeting convened to address the Agency’s progress in implementing the MDUFMA provisions as well as guidance issued by FDA under this law. It also provided a forum for the Agency to obtain feedback on the implementation of MDUFMA.